olympus_ureteroscopes_wa_series_and_attachments_a03.pdf
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INSTRUCTIONS FOR USE
Ureteroscope, Attachment
A0395
A0396
WA00395A
WA00396A
WA02943A
WA02944A
WA02946A
WA29040A
WA29040B
WA29041A
WA29041B
WA29042A
WA29042B
WA29048A
WA29048B
WA29049A
WA29049B
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CONTENTS
1 General Information............................................................. 5
1.1 User Instructions.......................................................... 5
1.2 Signal Words............................................................... 5
1.3 Conventions................................................................. 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........................................................ 8
2.4 Environment of Use..................................................... 8
2.5 General Warnings and Cautions.................................. 9
3 Upon Delivery.................................................................... 12
4 Product Description............................................................ 14
4.1 Ureteroscope............................................................. 14
4.2 Attachment................................................................. 22
4.3 Symbols..................................................................... 25
4.4 Warranty.................................................................... 27
5 Preparation........................................................................ 28
5.1 Safety Information for Preparation............................. 28
5.2 Inspection.................................................................. 28
5.3 Assembly and Connection......................................... 30
6 Use.................................................................................... 35
6.1 Safety Information for Use......................................... 35
6.2 Inserting the Surgical Instrument .............................. 37
7 After Use............................................................................ 40
8 Reprocessing..................................................................... 41
8.1 Safety Information for Reprocessing.......................... 41
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8.2
8.3
8.4
8.5
8.6
General Information for Reprocessing....................... 42
Manual Cleaning........................................................ 45
Automated Cleaning and Disinfection........................ 47
Maintenance.............................................................. 49
Sterilization................................................................ 49
9 Repair and Disposal........................................................... 51
9.1 Repair........................................................................ 51
9.2 Disposal..................................................................... 52
10 Compatible Equipment...................................................... 53
11 Technical Data................................................................... 55
11.1 General Dimensions.................................................. 55
11.2 Dimensions for Reprocessing.................................... 61
11.3 Specifications............................................................. 65
11.4 Classification of ME Equipment and ME Systems..... 65
11.5 Ambient Conditions.................................................... 65
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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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1.3 Conventions
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.
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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2 Safety Information
2.1 Intended Use
Ureteroscope
WA02943A, WA02944A, WA02946A, WA29040A,
WA29040B, WA29041A, WA29041B, WA29042A,
WA29042B, WA29048A, WA29048B, WA29049A,
WA29049B
Semi-rigid optical instrument for the visualization of the
following diagnostic and therapeutic procedures:
-- Transurethral inspection of the ureters and the kidneys for
diagnosis
-- Transurethral insertion of catheters, guide wires, cannulas,
forceps and electrodes into the urethra, the urinary bladder
and the ureters
-- Transurethral treatment and removal of tissue, catheters,
guide wires, debris and stones from the urethra, the urinary
bladder and the ureters
-- Transurethral treatment and removal of tissue and stones
from the ureters and the kidneys
• Do not use for any other purposes.
Attachment
A0395, A0396, WA00395A, WA00396A
Attachment for use in combination with a compatible
ureteroscope for the following applications:
-- Connection of the irrigation tubing
-- Insertion of compatible instruments
• 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 ureteroscope must be observed.
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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.
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.
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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 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.
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” in this document.
• 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.
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• 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 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.
• Repairs may only be performed by qualified servicing
personnel that has been authorized by Olympus.
• Contact your Olympus representative or an authorized
service center for repair information.
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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.
• Only use compatible equipment as listed in the chapter
“Compatible Equipment” in this document.
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.
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3 Upon Delivery
• Make sure that the shipping case contains all of the items
listed below.
• Contact an Olympus representative or an authorized service
center if any items are missing or damaged.
Contents
WA02943A, WA02944A, WA02946A
-- Ureteroscope (with light-guide adapter O0332 and A0460)
-- Instrument tray A5961
-- Instructions for use
-- System Guide Endoscopy
Contents
WA29040A, WA29041A, WA29048A, WA29049A
-- Ureteroscope
-- Instrument tray A5961
-- Attachment WA00395A
-- Sealing caps WA00387A
-- Instructions for use
-- System Guide Endoscopy
Contents
WA29040B, WA29041B, WA29048B, WA29049B
-- Ureteroscope
-- Instrument tray A5961
-- Attachment A0395
-- Sealing caps A0387
-- Instructions for use
-- System Guide Endoscopy
Contents
WA29042A
-- Ureteroscope
-- Instrument tray A5961
-- Attachment WA00396A
-- Sealing caps WA00387A
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-- Instructions for use
-- System Guide Endoscopy
Contents
WA29042B
-- Ureteroscope
-- Instrument tray A5961
-- Attachment A0396
-- Sealing caps A0387
-- Instructions for use
-- System Guide Endoscopy
Contents
A0395, A0396
-- Attachment
-- Sealing caps A0387
-- Access information sheet
Contents
WA00395A, WA00396A
-- Attachment
-- Access information sheet
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4 Product Description
4.1 Ureteroscope
A semi-rigid endoscope designed for the visualization of
diagnostic and therapeutic procedures.
There are single-channel ureteroscopes and dual-channel
ureteroscopes.
An image relay system of fiber bundles transmits the
endoscopic image.
A bundle of optical fibers transmits light from an external light
source to illuminate the endoscopic image.
Ureteroscopes are precise optical devices which are very
sensitive to mechanical impacts.
Entire ureteroscope
WA02943A
WA02944A
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WA02946A
WA29040A, WA29040B
WA29041A, WA29041B
WA29042A, WA29042B
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WA29048A, WA29048B
WA29049A, WA29049B
4.1.1 Ureteroscope WA02943A
1)
2)
3)
4)
Insertion tube
Light-guide adapter A0460
Light-guide adapter O0332
Light-guide connector
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5) Eyepiece cup
6) Finger rest
7) Instrument/irrigation port
8) Instrument/irrigation port
9) Finger rest
10) Blue ring
4.1.2 Ureteroscope WA02944A, WA02946A
1) Insertion tube
2) Light-guide adapter A0460
3) Light-guide adapter O0332
4) Light-guide connector
5) Finger rest
6) Eyepiece cup
7) Instrument/irrigation port
8) Instrument/irrigation port
9) Finger rest
10) Blue ring
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4.1.3 Ureteroscope WA29040A, WA29040B, WA29041A,
WA29041B, WA29042A, WA29042B
1)
2)
3)
4)
5)
6)
7)
Insertion tube
Light-guide connector
Eyepiece cup
Finger rest
Locking ring
Finger rest
Blue ring
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4.1.4 Ureteroscope WA29048A, WA29048B, WA29049A,
WA29049B
1)
2)
3)
4)
5)
6)
7)
Insertion tube
Light-guide connector
Finger rest
Eyepiece cup
Locking ring
Finger rest
Blue ring
4.1.5 Distal End
1) Instrument channel
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2) Objective cover glass
3) Light emission surface
4.1.6 Eyepiece Cup
1) Eyepiece cover glass
4.1.7 Light-Guide Connector
1) Light admission surface
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4.1.8 Direction of View and Minimum Instrument
Channel Width
WA02943A, WA02944A, WA02946A
-- The direction of view is indicated in degree under the
eyepiece cup.
-- The minimum instrument channel width is indicated in
French on the instrument/irrigation port.
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WA29040A, WA29040B, WA29041A, WA29041B,
WA29042A, WA29042B, WA29048A, WA29048B,
WA29049A, WA29049B
-- The direction of view is indicated in degree under the
eyepiece cup.
-- The minimum instrument channel width is indicated in
French on the locking ring.
4.2 Attachment
The attachment features Luer-Lock connectors (male) for the
connection of the irrigation tubing and the attachment of the
sealing cap(s). The instrument channel of the attachment
allows the insertion of surgical instruments. Stopcocks are
designed to control the flow of the irrigation fluid.
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4.2.1 Attachment A0395
1)
2)
3)
4)
5)
Locking cone
Stopcock
Sealing cap
Instrument channel
Irrigation port
4.2.2 Attachment A0396
1) Locking cone
2) Stopcock
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3) Sealing cap
4) Instrument channel
5) Irrigation port
4.2.3 Attachment WA00395A
1)
2)
3)
4)
5)
Locking cone
Stopcock
Sealing cap
Instrument channel
Irrigation port
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4.2.4 Attachment WA00396A
1)
2)
3)
4)
5)
Locking cone
Stopcock
Sealing cap
Instrument channel
Irrigation port
4.3 Symbols
This section gives an explanation for each symbol used on the
product and on the packing of the product.
Catalog number
Serial number
Batch code
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Quantity of content
Manufacturer
Date of manufacture
Consult instructions for use
Indicates the range of humidity to which the medical device
can be safely exposed
Indicates the temperature limits to which the medical device
can be safely exposed
Autoclavable
Green Dot symbol for dual recycling system
CE certification mark – symbol for the compliance with the
Medical Device Directive 93/42/EEC
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