INSTRUCTIONS FOR USE

TELESCOPE

ULTRA

WA4KL100 WA4KL500
WA4KL130 WA4KL530
WA4KL145 WA4KL545
Contents
1 General information................................................................. 5
1.1 User instructions..................................................................... 5
1.2 Signal words............................................................................ 5
1.3 Conventions throughout this document................................... 5
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.................................................................... 8
2.4 Environment of use................................................................. 8
2.5 General warnings and cautions............................................... 8

3 Product description............................................................... 12
3.1 Scope of delivery.................................................................. 12
3.2 Telescope.............................................................................. 12
3.3 Symbols................................................................................ 16
3.4 Warranty................................................................................ 16

4 Preparation............................................................................. 17
4.1 Safety information for preparation......................................... 17
4.2 Inspection.............................................................................. 17
4.3 Assembly and connection..................................................... 19

5 Use.......................................................................................... 21
5.1 Safety information for use..................................................... 21

6 After use................................................................................. 24
6.1 Removal and disassembly.................................................... 24
6.2 Preparation for reprocessing at the point of use................... 24

7 Reprocessing......................................................................... 26
7.1 Safety information for reprocessing....................................... 26
7.2 General information for reprocessing.................................... 27
7.3 Manual cleaning.................................................................... 30
7.4 Manual disinfection............................................................... 32
7.5 Automated cleaning and thermal disinfection....................... 33
7.6 Maintenance.......................................................................... 37
7.7 General information for sterilization...................................... 37
7.8 Validated sterilization methods.............................................. 38
7.9 Verified sterilization methods................................................ 42
7.10 Storage and handling.......................................................... 44

8 Repair, shipment and disposal............................................. 45

8.1 Repair.................................................................................... 45
8.2 Shipment............................................................................... 46
8.3 Disposal................................................................................ 46

9 Compatible equipment.......................................................... 47
9.1 For 5.4 mm telescopes.......................................................... 48
9.2 For 10 mm telescopes........................................................... 49

10 Technical data...................................................................... 50
10.1 General dimensions............................................................ 50
10.2 Specifications...................................................................... 50
10.3 Ambient conditions.............................................................. 50
 General information

1 General information

1.1 User instructions

•• Before use, thoroughly read the instructions for use.
•• If the 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.

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.

5
General information

•• 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
-- Cidex OPA®
are trademarks of their respective owner.

1.5 Manufacturer

Olympus Winter & Ibe GmbH

Kuehnstr. 61
22045 Hamburg
Germany

6
 Safety information

2 Safety information

2.1 Intended use

WA4KL100, WA4KL130, WA4KL145
The device is indicated for use in endoscopic surgery to visualize
treatment and inspection of organs within the thoracic and
abdominal cavities.
The device is also indicated for visualization of transanal and
transvaginal applications.
•• Do not use for any other purposes.

WA4KL500, WA4KL530, WA4KL545

The device is indicated for use in endoscopic surgery to visualize
treatment and inspection of organs within the thoracic and
abdominal cavities.
The device is also indicated for visualization of transanal and
transvaginal applications as well as transoral applications,
including but not limited to laryngeal, pharyngeal and tracheal
surgery.
•• Do not use for any other purposes.

2.2 Contraindications

There are no contraindications which would not equally apply for

open surgery in the fields of:
-- laparoscopy
-- thoracoscopy
-- transanal applications
-- transvaginal applications.

The device is not suited for procedures in which it would regularly

come in physical contact with the beating heart of the patient.
The operating physician must judge according to professional
standards whether a specific procedure is appropriate or not.

7
Safety information

2.3 User qualification

Medical use
This product is only intended to be used by a trained physician.
These instructions for use do not explain or discuss clinical
procedures.

Reprocessing
Reprocessing of the product may only be performed by qualified
hygiene personnel.

Repair
Repair of the product may only be performed by trained qualified
servicing personnel that has been authorized by Olympus.
Otherwise, Olympus cannot be held responsible for the safety
and performance of the product.

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
This product must be reprocessed according to the applicable
national and local standards and regulations.

2.5 General warnings and cautions

The following 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 or in the instructions for use of any product being
used with this product.

8
 Safety information

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 or damage to the
product.
•• Make sure to have the complete set of instructions for use.
•• Before use, thoroughly read these instructions for use and the
instructions for use of all other products that will be used during
the procedure.

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 17.
•• Do not use a damaged product or a product with improper
functioning.
•• Replace a damaged product or a product with improper
functioning.
•• If a defect occurs during a procedure, immediately replace the
product.

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 F-Type 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.

9
Safety information

•• 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 electric shock when using light sources with
noninsulated light-guide connectors.
•• Only use light sources or light-guide cables that meet at least
the same requirements of applied part classification.
•• 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.

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. Possible injuries
include mechanical injuries, electric shock, burns, and toxication.
•• Do not attempt to repair or modify the product.
•• Repairs may only be performed by qualified servicing
personnel that has been authorized by Olympus.
•• Contact an Olympus representative or an authorized service
center for repair information.

10
 Safety information

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 47.

CAUTION
Risk of injury to the user
There is a risk of injury to the user when using endoscopic
equipment in combination with laser equipment.
•• Use suitable protection measures (e.g., filters, protective
goggles).

NOTICE
Risk of damage to the product
The endoscope is a precise optical device. Careless handling
may damage the endoscope.
•• Always handle the endoscope with care.
•• Do not hold the endoscope by the distal end only.
•• Do not bend the insertion tube.

11
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.

WA4KL100, WA4KL130, WA4KL145, WA4KL500, WA4KL530,

WA4KL545:
-- 1 Telescope
-- 1 Instructions for use

3.2 Telescope

A telescope is a rigid endoscope. An image relay system of rod

lenses transmits the endoscopic image. A bundle of optical fibers
transmits light from an external light source to illuminate the
endoscopic image. The endoscopic image can be viewed using
the ocular or by connecting a compatible camera head.
Telescopes are precise optical devices which are very sensitive
to mechanical impacts.
For information on compatibility, refer to the chapter “Compatible
equipment” on page 47.

12
 Product description

3.2.1 Telescope WA4KL100, WA4KL130, WA4KL145

Entire telescope

Main body

1) Insertion tube
2) Light-guide connector
3) Eyepiece cup

13
Product description

3.2.2 Telescope WA4KL500, WA4KL530, WA4KL545

Entire telescope

Main body

1) Insertion tube
2) Light-guide connector
3) Eyepiece cup

3.2.3 Distal end

1) Objective cover glass

14
 Product description

2) Light emission surface

3.2.4 Eyepiece cup

1) Eyepiece cover glass

3.2.5 Direction of view

The direction of view is indicated in degree on the main body of

the telescope.

15
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 Autoclavable

Serial number CE certification mark – symbol

for the compliance with the
Medical Device Directive 93/42/
EEC
Quantity of content Federal (USA) law restricts this
device to sale by or on the order
of a physician
Manufacturer Consult instructions for use

Date of manufacture Storage conditions

Indicates a recovery/recyclable Transport conditions

package or package material

Green Dot-symbol for dual Indicates the temperature limits

recycling system to which the medical device can
be safely exposed
Indicates the range of humidity to
which the medical device can be
safely exposed

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.

16
 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 26.
•• Do not use a product that has not been reprocessed.
•• Before each use, inspect the product as described in the
section “Inspection” on page 17.
•• 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.

17
Preparation

General inspection of the telescope

•• Check that the product has:

-- no dents, cracks, bending, or deformations
-- 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.

CAUTION
Risk of injury to the user
There is a risk of damaging the eye when looking into the distal
end of the endoscope and the light source is switched on.
•• Do not look into the distal end of the endoscope when the light
source is switched on.

Checking the light transmission

•• Hold the distal end of the telescope against a lamp.
•• Look into the light-guide connector of the telescope.
Black dots indicate defective light-guide fibers.
•• Do not use a telescope with more than 25 to 30% defective
light-guide fibers.

Checking the image quality

•• Hold a piece of writing at approximately 50 mm from the
objective cover glass.
•• Only use the telescope if the writing is clearly visible through
the telescope.

18
 Preparation

•• Check that the image is not cloudy, out of focus or dark.

4.3 Assembly and connection

If force is required for assembly:
1. Check the compatibility of the equipment.
2. If necessary, dispose of the product and use another one.

4.3.1 Selecting compatible system components

•• Refer to the chapter “Compatible equipment” on page 47 to

identify the compatible system components.
•• Observe the instructions for use of the compatible system
components.

4.3.2 Connecting the light-guide cable

•• Refer to the chapter “Compatible equipment” on page 47 to

identify the compatible light-guide cable.
•• If applicable, remove inappropriate light-guide adapters from
the telescope.
•• Observe the instructions for use of the light-guide cable.

19
Preparation

1. Connect the light-guide cable to the light-guide connector of

the telescope.
2. Screw the light-guide cable onto the thread of the light-guide
connector.

4.3.3 Connecting the video adapter and/or camera head

•• Refer to the chapter “Compatible equipment” on page 47 to

identify the compatible equipment.
•• Observe the instructions for use of the compatible equipment.

20
 Use

5 Use

5.1 Safety information for use

WARNING
Risk of injury to the patient
There is a risk of electric shock if the following conditions apply
simultaneously:
-- The telescope is inserted in the patient.
-- The light-guide cable is connected to the telescope but not to
the light source.
-- The light source connector of the light-guide cable comes in
contact with a conductive surface.
•• Completely connect the endoscope before inserting the
endoscope into the patient.

WARNING
Risk of injury to the patient
When energized endoscopes are used in combination with HF
surgical equipment, there are several risks of injury to the patient.
•• Follow the instructions for use of all devices connected to the
endoscope for safe application.

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.

21
Use

•• 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.

CAUTION
Risk of injury to the patient
Light sources emit large amounts of energy. As a result, the
temperatures in front of the light emission surface increase.
There is a risk of thermal injury to the patient’s tissue.
•• Do not use high intensity illumination in cavities with small
lumens.
•• Do not use high intensity illumination when the distal end of the
endoscope is placed into close proximity to the tissue.
•• If the distal end is soiled and impairs proper visualization,
remove the endoscope and clean the distal end.

CAUTION
Risk of injury to the user
The light-guide connector on the endoscope becomes hot. There
is a risk of burns if the endoscope is held by hand for a longer
period.
•• Avoid touching the light-guide connector when holding the
endoscope.

CAUTION
Risk of injury to the user
When using a sterile bag during the procedure, the temperature
of the distal end increases significantly. There is a risk of burns to
the patient’s tissue and the sterile bag.
•• Switch the light source into standby mode when using the
sterile bag.

NOTICE
Risk of damage to the product
If activated laser equipment touches the energized endoscope,
the energized endoscope may be damaged.

22
 Use

•• Only ignite when the laser emission part is visible on the

endoscopic image.

23
After use

6 After use

6.1 Removal and disassembly

1. Switch off the light source.

CAUTION
Risk of injury to the user
The connectors on the endoscope become hot. There is a risk of
burns when touching the connectors.
•• Let the endoscope cool down after use.

2. Disconnect the light-guide cable from the light source.

3. Disconnect the light-guide cable from the telescope.
4. If applicable, remove the adapters.
5. If applicable, remove the camera head.

If force is required for disassembly, dispose of the product.

6.2 Preparation for reprocessing at the point of use

WARNING
Risk of injury to the patient and/or the medical personnel
If instruments are left in dry condition for a longer period, heavy
debris may dry to the instrument, leading to incrustations that
may be difficult to remove.
•• Reprocess this product immediately after use. Do not leave
used instruments overnight before reprocessing.
•• Olympus recommends to return the product from the point
of use to the cleaning area in dry condition to avoid protein
fixation caused by detergents or disinfectants.

Immediately after use

•• Prepare reusable instruments for later reprocessing directly in
the operating room immediately after use as described in this
section.

24
 After use

•• Remove heavy debris from the product by wiping with an

appropriate, single-use lint-free cloth or sponge.
•• Separate telescopes from other instruments.
•• Immediately after use, bring the product to the reprocessing
area.

Transport to the reprocessing area

The product can be transported in a wet or dry condition.
•• Contain the product during transport to avoid possible
environmental or personnel contamination.
•• If the product is immersed in detergents or disinfectants for
transport, make sure that the detergents or disinfectants do not
cause protein fixation.
•• If the product is transported in dry condition, make sure that
gross debris does not dry.
•• Reprocess the product according to the instructions in this
document.

25
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.
•• Only use reprocessing methods which have been validated for
the product.

WARNING
Risk of injury to the patient
When using plastic instrument trays for automated cleaning and
thermal disinfection, the detergent may not come in contact with
all parts of the endoscope. Ineffective cleaning and disinfection
may lead to infection of the patient.
•• Do not use plastic instrument trays for automated cleaning and
thermal disinfection of the endoscope.

WARNING
Risk of injury to the user
Patient debris and reprocessing chemicals are hazardous. There
is a risk of infection or skin irritation when they come into contact
with exposed skin.
•• Wear personal protective equipment to guard against
dangerous chemicals and potentially infectious material in
accordance with the applicable local guidelines.
•• During cleaning and disinfection or sterilization, wear
appropriate personal protective equipment, such as eye wear,
face mask, moisture-resistant clothing and chemical-resistant
gloves that fit properly and are long enough so that no part of
the skin is exposed.

26
 Reprocessing

NOTICE
Risk of damage to the product
If endoscopes touch each other during reprocessing, transport or
storage, damage to the endoscope may occur.
•• Avoid that the endoscopes touch each other or other devices
during reprocessing, transport or storage.

7.2 General information for reprocessing

Brand-new instruments
Treat brand-new instruments as if they have been used.
Brand-new instruments must be reprocessed using a complete
reprocessing cycle.

The reprocessing cycle

•• Reprocess the product according to the instructions in this
chapter.
•• To minimize the risk of infecting patients, users or third parties,
reprocess the endoscopic instrumentation before each use.
•• Contact your local hygiene representative for local standards
and regulations.

Manual cleaning or automatic cleaning

In general, this product can be cleaned manually or automatically
with sufficient results. Manual cleaning methods involve infection
risks for the personnel responsible for reprocessing. Automatic
methods reduce these risks and provide the advantage of
standardized, reproducible and validated procedures. Therefore,
Olympus recommends to generally prefer automatic cleaning
methods.

Validated for efficacy

Validated for efficacy means that the efficacy of the method
or agent has been validated for reprocessing this product as
described in this document.

27
Reprocessing

Verified for material compatibility

Verified for material compatibility means that according to current
knowledge the reprocessing method or agent does not negatively
affect materials or functional performance of the product.
Verified for material compatibility does not mean that
microbiological efficacy can be guaranteed.

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.

++ Method validated for microbiological/cleaning efficacy and

verified for material compatibility
+ Method verified for material compatibility
– Incompatible
o Contact an Olympus representative for additional
information.
# Not tested

28
 Reprocessing

Process All products

covered in
this document
Preparation at Deposition Wet +
the point of use
Dry +
Decontamination Preparation Selection according to the
cleaning and disinfection
procedures
Cleaning Manual Ultrasonic –
Alkaline detergent +
Acidic detergent #
Neutral detergent ++
Machine Alkaline detergent ++
Acidic detergent o
Neutral detergent +
Rinsing +
Disinfection Manual ++
Machine Chemical o
Thermal ++
Drying (dry Tmax 95 °C (203 °F)
heat) (max. 10 min)
Maintenance

Sterilization Moist heat Autoclave (prevacuum)

(preferred ++
method)
Low
temperature:
+
steam and
formaldehyde
Ethylene oxide +
Gas Plasma STERRAD® 100S ++
STERRAD® NX™/100NX™ ++
STERRAD® 50/200 ++

Increased wear
Some reprocessing methods may lead to increased wear of the
products.
•• Inspect the products thoroughly before use for traces of wear.

29
Reprocessing

Cleaning brush
In the following reprocessing instructions, Olympus uses the term
“appropriate surface brush”. Select an appropriate surface brush
according to the following information:
•• 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.

Instructions for using detergents

•• All components of the product must be completely immersed in
the detergent.
•• Select the immersion time and the concentration of the solution
in accordance with the instructions given by the manufacturer
of the detergent.
•• Make sure that there are no air bubbles.

Instructions for using alcohol

•• Refer to national and local guidelines regarding the approval of
using alcohol.

7.3 Manual cleaning

WARNING
Risk of injury to the patient and/or the medical personnel
There is an infection control risk when using insufficient
detergents.
•• Only use detergents which have been validated for the product.

WARNING
Risk of injury to the patient and/or the medical personnel
The cleaning efficacy may be compromised if the detergent fixes
proteins to the product.
•• Avoid any protein fixation prior to or during cleaning caused by
the reprocessing process.

30
 Reprocessing

NOTICE
Risk of damage to the product
Incompatible detergents may considerably damage Olympus
endoscopes and accessories.
•• Use only solutions that are approved and verified (for example
by FDA, DGHM or a comparable institution) and that are
certified by their manufacturers as safe for endoscopic
instrument cleaning and disinfection.
•• Select the immersion time and the concentration of the solution
in accordance with the instructions given by the manufacturer
of the detergent.

NOTICE
Risk of damage to the product
Detergents may contain various aggressive compounds which
can damage the product.
•• To remove residues, rinse the product thoroughly with
deionized water as described by the manufacturer of the
detergent.
•• Do not use tap water for rinsing because it might be
chlorinated.

7.3.1 Manual cleaning procedure

Manual cleaning of the telescope has been validated with the

following detergent:
-- Neodisher MediZym 2% manufactured by Chemische Fabrik
Dr. Weigert GmbH und Co. KG

1. Immerse the product in enzyme-based detergent for at least

15 min.
2. Thoroughly rinse the product and all gaps at least 10 times
with enzyme-based detergent using a syringe of at least
10 ml.
3. Thoroughly brush all gaps at least 10 times with an
appropriate surface brush.
Do not touch optical surfaces with the brush.

31
Reprocessing

4. Wipe the eyepiece cover glass and objective cover class with
a cotton swab that has been moistened with 70% ethanol
solution.
Do not wipe with a metal cotton applicator.
5. Thoroughly rinse the product and all gaps at least 10 times
with fresh enzyme-based detergent using a syringe of at least
10 ml.
6. 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).

7.4 Manual disinfection

NOTICE
Risk of damage to the product
Incompatible disinfectants may considerably damage Olympus
endoscopes and accessories.
•• Use only solutions that are approved and verified (for example
by FDA, DGHM or a comparable institution) and that are
certified by their manufacturers as safe for endoscopic
instrument cleaning and disinfection.
•• Select the immersion time and the concentration of the solution
in accordance with the instructions given by the manufacturer
of the disinfectant.

NOTICE
Risk of damage to the product
Disinfectant solutions or tap water may contain various
aggressive compounds that can damage the product.
•• To remove residues, rinse the product thoroughly with sterile
water.
•• Do not use tap water for rinsing because it might be
chlorinated.

32
 Reprocessing

7.4.1 Precondition for manual disinfection

The product must be cleaned thoroughly before disinfection.

Thorough cleaning removes both micro-organisms and organic
material. Failure to remove organic material decreases the
effectiveness of the disinfection process.
•• To avoid damaging the product, it is recommended to use
commercially available grasping forceps with rubber-padded
jaws to handle the product once it is immersed.
•• Grasp the product at its main body.

7.4.2 Manual disinfection procedure

1. Always refer to the latest instructions of the manufacturer of

the solution.
2. Completely immerse the product in Cidex OPA® Solution by
Johnson & Johnson. Ensure that all parts are covered.
3. Soak the product in Cidex OPA® Solution for as long as
recommended by the manufacturer of the solution, but for at
least 12 minutes.
4. Remove the product from the solution.
5. Rinse the product by completely immersing it in 8 liters of
sterile water for at least 1 minute.
6. Repeat the rinsing step twice. Always use fresh portions of
sterile water for each rinse.
7. Dry the product.

7.5 Automated cleaning and thermal disinfection

WARNING
Risk of injury to the patient and/or the medical personnel
There is an infection control risk when using insufficient
detergents.
•• Only use detergents which have been validated for the product.

33
Reprocessing

WARNING
Risk of injury to the patient
When using plastic instrument trays for automated cleaning and
thermal disinfection, the detergent may not come in contact with
all parts of the endoscope. Ineffective cleaning and disinfection
may lead to infection of the patient.
•• Do not use plastic instrument trays for automated cleaning and
thermal disinfection of the endoscope.

CAUTION
Risk of injury to the patient and/or the medical personnel
Insufficient detergents or disinfectants can lead to protein fixation
on the instrument. High inflow temperatures during automated
cleaning and thermal disinfection can cause thermal coagulation
of proteins.
•• Preferably return the product from the point of use to the
cleaning area in dry condition to avoid protein fixation caused
by detergents or disinfectants.
•• Make sure that the first water inflow into the washer-disinfector
during automated cleaning and thermal disinfection starts with
cold temperatures (<20 °C) to avoid thermal coagulation of
proteins.

Appropriate washer-disinfector with thermal disinfection

programs
•• Use only a washer-disinfector with thermal disinfection
programs which are specifically intended for cleaning and
disinfection of endoscopic instruments by the manufacturer.
•• Use only a washer-disinfector with thermal disinfection
programs in accordance with international standard series
ISO 15883.
•• Refer to the instructions for use of the washer-disinfector.
•• For automated cleaning, use alkaline detergent.

Detergents in automatic cleaning

•• Only use detergents which have been validated for the product.
•• Select the immersion time and the concentration of the solution
in accordance with the instructions given by the manufacturer
of the detergent.

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 Reprocessing

Automated cleaning of the product has been validated with the

following detergents:
-- Neodisher MediClean forte manufactured by Chemische Fabrik
Dr. Weigert GmbH und Co. KG
-- 0.5% solution
-- pH value: approx. 10.3
-- Neodisher Z manufactured by Chemische Fabrik Dr. Weigert
GmbH und Co. KG
-- 0.1% solution
-- pH value: approx. 1.2

NOTICE
Risk of damage to the product
Detergents or tap water may contain various aggressive
compounds that can corrode the product.
•• To remove residues, rinse the product thoroughly with
deionized water.
•• Do not use tap water for rinsing because it might be
chlorinated.

7.5.1 Preparation for automatic cleaning and thermal disinfection

•• Use adequate instrument trays to fix the product.

•• Make sure that the product has been securely fixed to the
trays or baskets of the washer-disinfector. Make sure that
instruments do not touch each other.
•• Refer to the instructions for use of the instrument tray and the
washer-disinfector.
•• Make sure that instruments are placed in the washer-disinfector
so that they can be appropriately cleaned and disinfected.
•• Do not overload the washer-disinfector.

7.5.2 Selection of programs

Select the program according to the following characteristics:

-- The program must at least reach an A0 value of 3000.
-- The temperature of the first inlet water must not exceed 20 °C.

35
Reprocessing

-- A temperature of 55 °C must not be exceeded during cleaning.

•• Do not use programs starting with high temperatures (e.g.,

93 °C). This causes thermal coagulation of proteins.
•• Make sure that the program does not include any sudden
changes in temperature.

Example for a program cycle:

1) Pre-rinse
2) Cleaning
3) Rinsing
4) Heating
5) Disinfection
6) Drying

7.5.3 After automated cleaning and thermal disinfection

•• To prevent corrosion, remove all instrument parts from the

washer-disinfector immediately after the automatic procedure is
completed.
•• If necessary, dry the instruments.

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 Reprocessing

7.6 Maintenance

Inspecting the telescope

•• 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 17.

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 General information for sterilization

Precondition for sterilization

The product must be cleaned thoroughly before sterilization.
Thorough cleaning removes both micro-organisms and
organic material. Failure to remove organic material decreases
effectiveness of the sterilization process. After cleaning, make
sure that the instrument is carefully dried.

Sterilization in plastic instrument trays

The sterilization of the endoscope in the plastic instrument tray
has been validated with steam sterilization only.
•• To ensure proper sterilization when using plastic instrument
trays, reprocess the product with steam sterilization only.

Storage life of sterilized instruments

The storage life of sterilized instruments depends on the type of
packaging and the storage conditions. Refer to national and local
laws and guidelines.

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Reprocessing

7.8 Validated sterilization methods

Sterilization of the product has been validated with steam

sterilization and STERRAD® sterilization.
•• Choose one of the sterilization methods.
•• For steam sterilization, refer to the section “Steam sterilization”
on page 38.
•• For STERRAD® sterilization, refer to the section “STERRAD®
sterilization” on page 41.

7.8.1 Steam sterilization

Preparing the telescope for steam sterilization

Using plastic instrument trays is one option to prepare the

product for steam sterilization.

Loading the instrument tray WA05990A (option)

1. Open the instrument tray.

2. Place the product into the instrument tray as shown in the

figure.

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 Reprocessing

3. Press the telescope into the notches.

4. Close the instrument tray.

5. Seal the instrument tray in packaging appropriate for
sterilization according to local guidelines and your hospital’s
protocol.

Use of instrument trays

•• Do not stack the instrument trays or load them on their side
edges during steam sterilization.

Steam sterilization conditions

Steam sterilization of the product has been validated with
fractionated prevacuum at 132 °C for 3 min.
Other possible steam sterilization parameters are:
Temperature.................................................... >132 °C (269.6 °F)
Holding time......................................................................... >3 min

NOTICE
Risk of damage to the product
Too high temperatures may damage the product.
•• Do not exceed a temperature of 138 °C. Otherwise, damage
may occur.

39
Reprocessing

•• After steam sterilization, let the instrument cool down gradually

to room temperature without additional cooling. Sudden
changes in temperature may damage the product.

Steam sterilization procedure

For steam sterilization, Olympus recommends a drying time of at
least 15–30 minutes.
•• Choose an appropriate drying time, depending on the
autoclave.
•• Refer to the autoclave’s instructions for use.
•• Be careful when unloading the autoclave, the contents may be
hot.
•• Make sure that the sterile packaging of the product is not
damaged.
•• Resterilize the product if 1 of the following applies:
-- the sealing has been opened
-- the packaging is wet
-- the packaging is damaged

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 Reprocessing

Example for fractionated prevacuum steam sterilization

1) Evacuation
2) Steaming and evacuation 2x
3) Heating
4) Sterilization
5) Evacuation
6) Drying
7) Aeration

7.8.2 STERRAD® sterilization

CAUTION
Risk of injury to the patient
Performing a STERRAD® sterilization with the endoscope in the
plastic instrument tray may lead to residues on the endoscope.
There is a risk of an allergic reaction to the patient.

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Reprocessing

•• When sterilizing the endoscope in the plastic instrument tray,

do not use STERRAD®.

Preparing the product for STERRAD® plasma sterilization

•• Place the product in sterilizing pouches or containers (any
container/pouches must be certified by its manufacturer for
STERRAD® use).
•• Only use sterilization accessories that have been cleared
by the local authorities for the use within the respective
STERRAD® system.
•• Refer to the instructions for use of the sterilizer.

STERRAD® systems
Different STERRAD® systems with different cycles exist in the
market. The information provided on STERRAD® sterilization in
this document applies to the following STERRAD® systems and
cycles:
-- STERRAD® 50: only 1 cycle
-- STERRAD® 100S: short cycle and long cycle
-- STERRAD® 200: short cycle and long cycle
-- STERRAD® NX™: standard cycle and advanced cycle
-- STERRAD® 100NX™: standard cycle and express cycle

7.9 Verified sterilization methods

The sterilization methods described in this section have been

verified for material compatibility only.
Verified for material compatibility means that according to
current knowledge the reprocessing method and/or agent does
not negatively affect materials or functional performance of the
product.
Verified for material compatibility does not mean that
microbiological efficacy can be guaranteed.

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 Reprocessing

7.9.1 Gas Sterilization

WARNING
Risk of injury to the patient and/or the medical personnel
Residual water can affect the gas sterilization process and lead
to insufficient reprocessing.
•• Thoroughly clean and dry the instruments before gas
sterilization.

WARNING
Risk of injury to the patient and the user
Toxic gasses can enter internal volumes of the product during
gas sterilization. The gasses can remain in the product and can
leak out during use.
•• To remove toxic gasses, aerate the product sufficiently after
sterilization.

Gas sterilization of the product has been verified with the

following sterilization procedures:
-- 100% ethylene oxide gas sterilization
-- 55° C low-temperature steam and formaldehyde gas
sterilization (LTSF)

Conditions for ethylene oxide gas sterilization

•• Do not exceed the parameters outlined in the chart below.
Gas concentration............................................................. 735 mg/l
Temperature........................................................... 55 °C (130 °F)
Relative humidity................................................................50–70%
Exposure time..................................................................... 60 min.
Aeration time..........................................................2:45 h or longer

Gas sterilization procedure

•• Place the product in appropriate instrument trays or pouches.
•• Refer to the sterilizer’s instructions for use.
•• Aerate the product sufficiently.

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Reprocessing

7.10 Storage and handling

NOTICE
Risk of damage to the product
If the product is stored or transported with other devices without
use of an instrument tray, product damage may occur.
•• Use instrument trays to store or transport the product.
•• Load instruments separately into instrument trays.
•• Only remove instruments from the instrument tray directly
before use.

NOTICE
Risk of damage to the product
The endoscope is a precise optical device. Careless handling
may damage the endoscope.
•• Handle and store endoscopic equipment carefully.
•• Do not subject it to mechanical shocks, such as impact or fall.

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 Repair, shipment and disposal

8 Repair, shipment and disposal

8.1 Repair
WARNING
Risk of injury to the patient and/or the user
There is a risk of damage to the product if the user or an
unauthorized servicing agency attempts repair of a product. A
damaged product may cause injury of the patient or the user.
•• Only let qualified servicing personnel that has been authorized
by Olympus carry out repairs.

There is a repair service for the following products only:

WA4KL100, WA4KL130, WA4KL145, WA4KL500, WA4KL530,
WA4KL545

Authorized service centers

Repairs may only be performed by qualified servicing personnel
that has been authorized by Olympus. Contact an Olympus
representative or an authorized service center for repair and
warranty information.
Otherwise, Olympus can not be held responsible for the safety,
reliability, and performance of the product.

Loss of warranty
Any guarantee or warranty claims are forfeited if the user or an
unauthorized servicing agency attempts repair of a product.

Description of defects
To enable the Service Center to perform repairs in a timely
manner, send the product together with a detailed description
of the damage or defect. The following particulars should be
included:
-- Catalog number
-- Serial number or lot number (if possible)
-- Precise description of the malfunction
-- Delivery date
-- Invoice copy (for possible guarantee or warranty claims)

45
Repair, shipment and disposal

-- Internal order number of the customer (for correct accounting of

the repair order)

8.2 Shipment
WARNING
Risk of infection for the servicing personnel
Sending used products to Olympus represents a risk of infection
for the personnel. Olympus is entitled to refuse soiled or
contaminated products for reasons of safety.
•• Reprocess the product before sending in.
•• If reprocessing will damage the product completely, clean the
product as thoroughly as possible and mark it accordingly.

When sending products to an authorized service center for repair

and/or warranty claims, note the following.
•• Use the original cardboard packaging for the transport of the
product.
If this is not possible, wrap each component individually in
sufficient paper or sheets of foamed material and place them in
a cardboard box.
•• If applicable, use the respective transport protection (e.g.
instrument tray) of the product.

Service centers do not accept warranty claims for damage

caused by inadequate packaging.

8.3 Disposal

When disposing of the product or any of its components, follow

all applicable national and local laws and guidelines.

46
 Compatible equipment

9 Compatible equipment
Olympus recommends the use of equipment as listed in this
chapter. If combinations are used that are not listed in this
chapter, the user takes the full responsibility.
Future equipment may also be compatible. For more information,
contact an Olympus representative.
Some of the products listed in this chapter may not be available
in all sales territories.

CAUTION
Risk of injury to the patient and/or the user
When using endoscopes and light-guide cables with an
inappropriate combination of the maximum insertion portion width
and fiber bundle diameter, the connectors may become hot.
•• Only use endoscopes and light-guide cables with the
appropriate combination of the maximum insertion portion
width and fiber bundle diameter.
•• For the appropriate maximum insertion portion width of the
telescope, refer to the chapter “Technical data” on page 50.
•• For the appropriate fiber bundle diameter, refer to the
respective instructions for use of the light-guide cable.

Light-guide cables
Olympus recommends the use of an Olympus light-guide
cable and an Olympus light source. Only this combination will
guarantee optimum illumination of the endoscopic image and
excellent color reproduction.
Using endoscopes in combination with light-guide cables of other
manufacturers may lead to an increase in temperature of the
connectors.

47
Compatible equipment

9.1 For 5.4 mm telescopes

A0464

O0332 A0460

WA4KL500

WA4KL530

WA4KL545

No. Product description Article number

* Instrument trays and wire baskets e.g. WA05990A, A5940
** Light-guide cable e.g. WA03310A
*** High-resolution camera head e. g. CH-S190-XZ-E, OTV-S7 ProH-
HD-10E, OTV-S7 ProH-HD-12E
**** 5.5 mm trocars e.g. A5946, A5809

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 Compatible equipment

9.2 For 10 mm telescopes

A0464

O0332 A0460

WA4KL100

WA4KL130

WA4KL145

No. Product description Article number

* Instrument trays and wire baskets e.g. WA05990A, A5940
** Light-guide cable e.g. WA03310A
*** High-resolution camera head e. g. CH-S190-XZ-E, OTV-S7 ProH-
HD-10E, OTV-S7 ProH-HD-12E
**** 11 mm trocars e.g. A5822, A5859

49
Technical data

10 Technical data

10.1 General dimensions

10.1.1 Telescope

Working length
WA4KL100...................................................................... 316.4 mm
WA4KL130...................................................................... 318.6 mm
WA4KL145...................................................................... 319.2 mm
WA4KL500...................................................................... 315.8 mm
WA4KL530...................................................................... 317.0 mm
WA4KL545...................................................................... 317.0 mm

Maximum insertion portion width

WA4KL100, WA4KL130, WA4KL145................................ 10.2 mm
WA4KL500, WA4KL530, WA4KL545................................ 5.45 mm

10.2 Specifications

Direction of view
WA4KL100, WA4KL500..............................................................0°
WA4KL130, WA4KL530............................................................30°
WA4KL145, WA4KL545............................................................45°

Field of view
WA4KL100, WA4KL130, WA4KL145........................................88°
WA4KL500, WA4KL530, WA4KL545........................................84°

10.3 Ambient conditions

Operating conditions
Ambient temperature...............................10 to 35 °C (50 to 95 °F)
Relative humidity.............................................................30 to 85%
Atmospheric pressure...........................................700 to 1060 hPa

50
 Technical data

Storage conditions
Temperature..........................................10 to 40 °C (50 to 104 °F)
Relative humidity.............................................................30 to 85%

Transport conditions
Temperature..................................... −40 to 70 °C (−40 to 158 °F)
Relative humidity.............................................................10 to 95%

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2018-06-07
en © Copyright 2018 Olympus Winter & Ibe GmbH