Olympus OES ELITE Manuale utente
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 qualication ................................................................... 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 Specications..................................................................... 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-specic 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 qualication
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 qualied
hygiene personnel.
Repair
Repair of the product may only be performed by trained qualied
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 insufcient 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 conicting 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 classication 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 classication.
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 classication, 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 classication.
• For the applied part classication, 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 modication. 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 qualied servicing
personnel that has been authorized by Olympus.
• Contact an Olympus representative or an authorized service
center for repair information.
Questo manuale è adatto per i seguenti modelli
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