Olympus WA4KL100 ULTRA User manual

INSTRUCTIONS FOR USE
TELESCOPE
ULTRA
WA4KL100
WA4KL130
WA4KL145
WA4KL500
WA4KL530
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 qualication ................................................................... 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 Veried 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 Specications..................................................................... 50
10.3 Ambient conditions............................................................. 50

5
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.

6
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

7
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 elds 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 specic procedure is appropriate or not.

8
Safety information
2.3 User qualication
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 qualied
hygiene personnel.
Repair
Repair of the product may only be performed by trained qualied
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.

9
Safety information
WARNING
Risk of injury to the patient and/or the user
An insufcient 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 classication of
the endoscopic equipment and especially the energized
endotherapy devices used during the procedure.

10
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 classication.
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 classication, 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 classication.
• For the applied part classication, 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 modication. 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 qualied servicing
personnel that has been authorized by Olympus.
• Contact an Olympus representative or an authorized service
center for repair information.

11
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., lters, 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.

12
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 bers
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.

13
Product description
3.2.1 Telescope WA4KL100, WA4KL130, WA4KL145
Entire telescope
Main body
1) Insertion tube
2) Light-guide connector
3) Eyepiece cup

14
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

15
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.

16
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 certication 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
package or package material
Transport conditions
Green Dot-symbol for dual
recycling system
Indicates the temperature limits
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 modication of the
product. No warranty is provided for any damage due to misuse
of the product.

17
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 rst 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.

18
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 bers.
• Do not use a telescope with more than 25 to 30% defective
light-guide bers.
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.

19
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.

20
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.