Bougie and Guiding Tubes Instruction for Use

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

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

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

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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

Terminology 2) Proximal end 3) Channel for guide wire WA37031A

1) Distal end 2) Indication of French size 3) Proximal end

8

Technical data

3 Technical data Diameter WA33027A... 9–28 Fr. WA33028A... 21 Fr. WA37031A... 13.5 Fr.

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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.

WA33027A ≤ 23 Fr./Ch. (no./Nr. 6)

WA33035A WA33037A

WA33027A ≤ 15 Fr./Ch. (no./Nr. 3)

WA33028A

WA33027A ≤ 25 Fr./Ch. (no./Nr. 7)

WA33027A ≤ 12 Fr./Ch. (no./Nr. 2)

WA33038A

WA37031A

A37022A

WA33028A ∅ ≤ 3 Fr./ Ch.

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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.

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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.

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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.

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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.

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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

+

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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.

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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.

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W7514750_1-0 2016-03-18 en

© Copyright 2016 Olympus Winter & Ibe GmbH