OLYMPUS Bougie and Guiding Tubes Instruction for Use WA37031A March 2016.pdf
Page 1
INSTRUCTIONS FOR USE
BOUGIE TUBES, GUIDING TUBES
WA33027A
WA33028A
WA37031A
Page 3
Contents
1 General information................................................................. 5
1.1 Upon delivery.......................................................................... 6
1.2 Manufacturer........................................................................... 6
2 Terminology.............................................................................. 7
3 Technical data.......................................................................... 9
4 Compatible components....................................................... 10
5 Before use.............................................................................. 11
5.1 Inspection and testing........................................................... 11
6 Use.......................................................................................... 12
6.1 Procedure.............................................................................. 12
6.2 After use................................................................................ 14
7 Reprocessing......................................................................... 15
7.1 Cleaning................................................................................ 16
8 Repair...................................................................................... 17
Page 5
General information
1 General information
Intended use
WA33027A
Set of bougie tubes for use in percutaneous nephroscopy.
WA33028A
Guiding tube for use in conjunction with the WA33027A set of
bougie tubes.
WA37031A
Guiding tube for use in conjunction with the WA33027A set of
bougie tubes in pediatric percutaneous nephroscopy. Do not use
it for any other purpose.
Medical use
This product is to be used only in a medical facility by trained
medical personnel.
NOTE!
Instruction manual set
The complete instruction manual set for this product consists of
this product-specific instruction manual (delivered together with
this product) and the system-related instruction manual, entitled
“System Guide Endoscopy” (supplied with Olympus telescopes).
Immediately contact an Olympus representative if either manual
is missing or lost. Keep the instruction manual set in a safe,
accessible location.
WARNING!
Read all instruction manuals thoroughly
Before use, read this manual, the System Guide Endoscopy, and
the manuals for all other equipment which will be used during
the procedure. An insufficient understanding of the dangers,
warnings, cautions, and information in these manuals can result
in death, serious injury, or equipment damage.
5
Page 6
General information
Medical Device Directive (Europe)
This product complies with the requirements of Directive 93/42/
EEC concerning medical devices.
1.1 Upon delivery
Inspect immediately
•• Make sure that the shipping case contains all items.
•• Contact your Olympus representative or an authorized service
center if any items are missing or damaged.
Unpacking
•• Remove the product from the packaging. Do not use the
packaging for routine storage.
1.2 Manufacturer
Olympus Winter & Ibe GmbH
Kuehnstr. 61
22045 Hamburg
Germany
6
Page 7
Terminology
2 Terminology
WA33027A
1)
2)
3)
4)
5)
Distal opening of guiding tube
Guiding tube
Bougie tubes 1-8
Indication of French size
Number of bougie tube
WA33028A
1) Distal end
7
Page 8
Terminology
2) Proximal end
3) Channel for guide wire
WA37031A
1) Distal end
2) Indication of French size
3) Proximal end
8
Page 9
Technical data
3 Technical data
Diameter
WA33027A......................................................................... 9–28 Fr.
WA33028A............................................................................. 21 Fr.
WA37031A.......................................................................... 13.5 Fr.
9
Page 10
Compatible components
4 Compatible components
WARNING!
Risk of injury to the patient and/or user
Use only compatible equipment as listed in this section. If other
combinations are used, the full responsibility is assumed by the
user. Future products may also be compatible. For further details
contact an Olympus representative.
WA33035A
WA33037A
WA33027A
≤ 23 Fr./Ch. (no./Nr. 6)
WA33028A
WA33027A
≤ 15 Fr./Ch. (no./Nr. 3)
WA33027A
≤ 25 Fr./Ch. (no./Nr. 7)
WA33027A
≤ 12 Fr./Ch. (no./Nr. 2)
WA33038A
WA37031A
A37022A
WA33028A
∅ ≤ 3 Fr./ Ch.
10
Page 11
Before use
5 Before use
WARNING!
Infection control risk
Properly reprocess the product before first and each subsequent
use following the instructions in this manual and in the System
Guide Endoscopy. Improper and/or incomplete reprocessing can
cause infection of the patient and/or medical personnel.
5.1 Inspection and testing
Inspecting the product
Visually inspect the product. Make sure that it has:
-- no corrosion
-- no dents
-- no scratches
Damaged product
If the product is damaged or does not function properly, contact
an Olympus representative or an authorized service center.
11
Page 12
Use
6 Use
Before use
Make sure that the product has been properly reprocessed,
inspected, and tested.
6.1 Procedure
Placing the guide wire
1) Assisted by X-ray and ultrasound, insert a hollow needle and
advance it into the renal pelvis.
2) Insert a compatible guide wire into the hollow needle and
advance it into the renal pelvis.
3) Remove the hollow needle.
12
Page 13
Use
Inserting the bougie tubes
1) Remove the bougie tubes from the guiding tube (only for
WA33027A).
2) Insert the guide wire’s end into the distal opening of the
guiding tube.
3) Advance the guiding tube into the renal pelvis.
4) Successively insert the required amount of bougie tubes over
the guiding tube to dilate the puncture to the required width.
Placing a second guide wire (not for WA37031A)
•• Insert the WA33028A guiding tube after bougie tube no. 3.
•• Insert a compatible guide wire into the guiding tube’s channel
and advance it into the renal pelvis.
•• Remove the WA33028A guiding tube.
Use of WA37031A (pediatric percutaneous nephroscopy)
•• Insert the WA37031A guiding tube after bougie tube no. 2.
13
Page 14
Use
Insert the sheath
•• Insert a compatible sheath over the bougie tubes into the
patient (refer to the sheath’s instruction manual).
•• Remove the bougie tubes from the sheath.
6.2 After use
Withdrawal
•• Withdraw the complete instrument from the patient.
Reprocessing
•• Immediately bring the product to the reprocessing area.
•• Reprocess the product following the instructions in this manual
and in the System Guide Endoscopy.
14
Page 15
Reprocessing
7 Reprocessing
WARNING!
Infection control risk
Properly reprocess the product before first and each subsequent
use following the instructions in this manual and in the System
Guide Endoscopy. Improper and/or incomplete reprocessing can
cause infection of the patient and/or medical personnel. Observe
the following instrument-specific instructions.
Information in this section
The following reprocessing information supplements that in the
System Guide Endoscopy. However, if the information given in
this section differs from that in the System Guide Endoscopy, use
the information given here.
Compatible reprocessing methods.
This product is compatible with the reprocessing methods listed
in the table. For details of the procedures, refer to the Olympus
Endoscopy System Guide.
+
compatible
−
incompatible
Manual or automatic cleaning
+
Ultrasonic cleaning
+
Disinfection or high-level disinfection
+
Steam sterilization (autoclaving)
+
Heat sterilization (dry)
−
Gas sterilization (ETO)
+
Gas sterilization (formaldehyde)
+
STERRAD 50/100/100S
+
STERIS
+
15
Page 16
Reprocessing
CAUTION!
Risk of damaging the product
Do not use incompatible reprocessing methods. Product damage
may occur.
7.1 Cleaning
Cleaning the bougie tubes and guiding tubes
•• Clean the inside of each bougie tube and of the WA33028A
and WA37031A guiding tubes with suitable cleaning brushes.
•• Use the A0452 cleaning brush to clean the guiding tube of
WA33027A.
16
Page 17
Repair
8 Repair
Policy
Contact your Olympus representative or an authorized service
center for repair and warranty information.
Repair guidelines
Follow the general repair guidelines in the System Guide
Endoscopy.
17
Page 20
W7514750_1-0
2016-03-18
en
© Copyright 2016 Olympus Winter & Ibe GmbH