Olympus OES ELITE User manual

INSTRUCTIONS FOR USE
TELESCOPE
WA2P400A
WA2T400A
WA2T412A
WA2T430A
WA2T470A
WA2T412P
WA2T430P
WA2T470P
WA2T43WA

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 ................................................................... 8
2.3 User qualication ................................................................... 8
2.4 Environment of use ................................................................ 8
2.5 General warnings and cautions.............................................. 9
3 Product description .............................................................. 12
3.1 Scope of delivery ................................................................. 12
3.2 Telescope............................................................................. 12
3.3 Protective tube ..................................................................... 16
3.4 Symbols ............................................................................... 17
3.5 Warranty............................................................................... 18
4 Preparation ............................................................................ 19
4.1 Safety information for preparation........................................ 19
4.2 Inspection............................................................................. 19
4.3 Assembly and connection .................................................... 21
5 Use.......................................................................................... 23
5.1 Safety information for use .................................................... 23
5.2 Procedure............................................................................. 24
6 After use ................................................................................ 25
6.1 Removal and disassembly ................................................... 25
6.2 Attaching the telescope to the protective tube ..................... 25
6.3 Preparation for reprocessing at the point of use .................. 26

7 Reprocessing ........................................................................ 27
7.1 Safety information for reprocessing...................................... 27
7.2 General information for reprocessing................................... 28
7.3 Manual cleaning................................................................... 31
7.4 Manual disinfection .............................................................. 33
7.5 Automated cleaning and disinfection ................................... 33
7.6 Maintenance......................................................................... 34
7.7 Sterilization........................................................................... 34
8 Repair, shipment and disposal ............................................ 39
8.1 Repair................................................................................... 39
8.2 Shipment.............................................................................. 39
8.3 Disposal ............................................................................... 40
9 Compatible equipment ......................................................... 41
10 Technical data ..................................................................... 45
10.1 General dimensions ........................................................... 45
10.2 Dimensions for reprocessing.............................................. 46
10.3 Specications..................................................................... 46
10.4 Ambient conditions............................................................. 46

5
General information
1 General information
1.1 User instructions
The complete set of instructions for use for this product consists
of the product-specic 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 the
HF equipment 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.

6
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
- 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
Olympus telescopes are designed for the visualization of
endoscopic diagnosis and treatment in the following elds of
application:
- Urology
- Gynecology
- Otorhinolaryngology
Telescope
WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA
In urology:
- Cystoscopy
- Resectoscopy
- Urethrotomy
In gynecology:
- Hysteroscopy
- Resectoscopy
In otorhinolaryngology:
- Laryngeal, pharyngeal and tracheal surgery
• Do not use for any other purposes.
Telescope
WA2T412P, WA2T430P, WA2T470P
In urology:
- Photodynamic diagnosis (PDD)
- Cystoscopy
- Resectoscopy
• Do not use for any other purposes.
Protective tube
WA2P400A
Protective tube to protect OES ELITE telescopes during
transport, storage and steam sterilization.

8
Safety information
• 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 telescope must be observed.
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.

9
Safety information
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, 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 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.
• Follow the dangers, warnings, cautions, and instructions in the
“System Guide Endoscopy”.
• In case of conicting information, follow the dangers, warnings,
cautions, and instructions in this document.
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 19.
• 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.

10
Safety information
• Before each use, check the applied part classication 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 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 41.
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.
• Always store and transport the endoscope in the supplied
protective tube.
• Remove the endoscope from the protective tube only before
direct use, manual cleaning or automated cleaning and
disinfection.

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.
WA2T400A, WA2T412A, WA2T430A, WA2T470A, WA2T43WA:
- Telescope
- Protective tube WA2P400A
- Instructions for use
- System Guide Endoscopy
WA2T412P, WA2T430P, WA2T470P:
- Telescope (with light-guide adapter A0460)
- Protective tube WA2P400A
- Instructions for use
- System Guide Endoscopy
WA2P400A:
- Protective tube
- Access information sheet
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.
A PDD telescope is designed for endoscopic diagnosis,
especially photodynamic diagnosis (PDD). A lter exclusively
designed for PDD is built into the telescope. Light of suitable
wavelength passes through the lter and enhances visualization.
Telescopes are precise optical devices which are very sensitive
to mechanical impacts.

13
Product description
For information on compatibility, refer to the chapter “Compatible
equipment” on page 41.
3.2.1 Telescope WA2T400A, WA2T412A, WA2T430A, WA2T470A,
WA2T43WA
Entire telescope
Main body
1) Insertion tube
2) Connector pin
3) Light-guide connector
4) Color code
Green: 0° direction of view
Blue: 12° direction of view
Red: 30° direction of view
Yellow: 70° direction of view
5) Eyepiece cup

14
Product description
3.2.2 PDD telescope WA2T412P, WA2T430P, WA2T470P
Entire telescope
Main body
1) Insertion tube
2) Connector pin
3) Light-guide adapter A0460
4) Light-guide connector
5) Color code
Blue: 12° direction of view
Red: 30° direction of view
Yellow: 70° direction of view
Purple: for use in photodynamic diagnosis (PDD)
6) Eyepiece cup

15
Product description
3.2.3 Distal end
1) Objective cover glass
2) Light emission surface
3.2.4 Eyepiece cup
1) Eyepiece cover glass

16
Product description
3.2.5 Direction of view
The direction of view is indicated in degree on the main body of
the telescope.
3.3 Protective tube
The protective tube is a rigid tubular device that protects the
telescope from mechanical stress during transport, storage
and steam sterilization. It is made of a polymer material. The
dimensions of the protective tube are harmonized with the
dimensions of the respective compatible telescope to cover the
fragile parts of the telescope. The protective tube features a
connecting mechanism to ensure a reliable connection to the
compatible telescope.
For information on compatibility, refer to the chapter “Compatible
equipment” on page 41.

17
Product description
WA2P400A
1) Distal end
2) Clamping piece
3) Proximal end
3.4 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 In combination with a high
resolution camera head and
monitor a high resolution image
can be displayed
Quantity of content Storage conditions
Manufacturer Transport conditions
Date of manufacture Green Dot-symbol for dual
recycling system
Caution, consult accompanying
documents
Indicates a recovery/recyclable
package or package material
Consult instructions for use Federal (USA) law restricts this
device to sale by or on the order
of a physician

18
Product description
Symbol Explanation Symbol Explanation
Indicates the range of humidity to
which the medical device can be
safely exposed
CE certication mark – symbol
for the compliance with the
Medical Device Directive 93/42/
EEC
Indicates the temperature limits
to which the medical device can
be safely exposed
CE certication mark – symbol
for the compliance with the
Medical Device Directive 93/42/
EEC
3.5 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.

19
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 27.
• Do not use a product that has not been reprocessed.
• Before each use, inspect the product as described in the
section “Inspection” on page 19.
• 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.

20
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 15 mm from the
objective cover glass.
• Only use the telescope if the writing is clearly visible through
the telescope.