RETRACTOR Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 6 1.2 Manufacturer/Distributor... 6 2 Terminology... 7 3 Technical data... 8 4 Compatible components... 9 5 Before use... 10 5.1 Inspection and testing... 10 6 Use... 12 6.1 Procedure... 12 6.2 After use... 14 7 Reprocessing... 15 7.1 Cleaning... 17 7.2 Maintenance... 18 8 Repair... 19

General information

1 General information Intended use WA51190A, WA51193A Retractor for moving tissue in thoracoscopic and laparoscopic applications. 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. Medical Device Directive (Europe) This product complies with the requirements of Directive 93/42/ EEC concerning medical devices.

5

General information

1.1 Upon delivery Inspect immediately •• Make sure that the shipping case contains all of the items listed below. •• Contact your Olympus representative or an authorized service center if any items are missing or damaged. Contents •• Retractor with sealing cap •• 1 additional sealing cap •• Instruction manual Unpacking Remove the product from the packaging. Do not use the packaging for routine storage.

1.2 Manufacturer/Distributor Manufacturer Jakoubek Medizintechnik GmbH Auf der Höhe 15 78576 Emmingen-Liptingen Germany Initial distributor: Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

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Terminology

2 Terminology Retractor

WA51190A WA51193A

1) 2) 3) 4) 5)

Fan blades Deflectable distal part (with fan blades) Rotation ring Luer-lock connector with sealing cap Knurled nut

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Technical data

3 Technical data Diameter WA51190A... 5 mm WA51193A... 10 mm Working length WA51190A... 360 mm WA51193A... 380 mm

8

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. NOTE Product may not be available in all sales territories.

11 mm

WA51193A

5.5 mm

WA51190A

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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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Before use Test the instrument

•• Make sure that the sealing cap is attached. •• Turn the knurled nut. Make sure that the fan blades open and close smoothly. •• Turn the rotation ring. The retractor’s distal part must deflect. Replace if necessary If the instrument is damaged or does not function properly, replace it.

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Use

6 Use Before use Make sure that the product has been properly reprocessed, inspected, and tested.

6.1 Procedure Insert the trocar tube •• Insert a compatible trocar tube into the patient. •• Follow the procedure in the trocar tube’s instruction manual. Insert the retractor

•• Make sure that the sealing cap is attached to the retractor’s Luer-lock connector. •• Make sure that the fan blades are closed completely. •• Make sure that the retractor’s distal part is not deflected. •• Insert the retractor’s distal part into the proximal opening of the trocar tube. •• If necessary, open the trocar tube’s valve. •• Insert the retractor into the patient under visual control.

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Use WARNING Risk of injury Do not rotate the retractor in the patient when the distal part is deflected and/or the fan blades are open. There is a risk of injury. CAUTION Risk of damaging the instrument Hand instruments may be damaged if excess force is applied or if the instrument is used in a manner for which it is not intended. In order to avoid damage, make sure that the force applied to the handle is adequate and reasonable for the intended application. Procedure

•• Open the fan blades by turning the knurled nut. •• Deflect the retractor’s distal part by turning the rotation ring. •• Perform the procedure.

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Use

6.2 After use Withdrawal

•• Bring the retractor’s distal part into straight position. •• Close the fan blades. •• Remove the retractor from the trocar tube. Preparation for reprocessing at the point of use •• 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 (according to ISO 17664) The microbiological efficacy and/or material compatibility of the reprocessing methods listed in the table have been validated or verified with this product. For details of the reprocessing procedures, refer to the System Guide Endoscopy. ++ + – ®, ™

Method validated for microbiological efficacy and verified for material compatibility Method verified for material compatibility Incompatible Products are trademarks of their respective owners

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Reprocessing Process

WA51190A WA51193A

Preparation at the point of use

Deposition

Wet

+

Dry

Decontamination

Preparation

Selection according to the cleaning and disinfection procedures

+

Cleaning

Manual

++

Machine

++

Ultrasonic

+

Alkaline detergent

+

Acidic detergent

–

Neutral detergent

+

Rinsing Disinfection

+ Chemical

+

Thermal Drying

+ 141 °C (max. 10 min.)

Tmax

Maintenance Sterilization

Moist heat (preferred method)

Autoclave (prevacuum)

++

Low temperature: steam and formaldehyde

–

Ethylene oxide

–

Dry heat Gas Plasma

– STERRAD® 50/100S

–

STERRAD 200/ NX™/100NX™

–

®

CAUTION Risk of damaging the product Do not use incompatible reprocessing methods. Product damage may occur.

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Reprocessing

7.1 Cleaning Preparing the retractor for cleaning

•• Open the fan blades completely. •• Deflect the retractor’s distal part completely. •• Remove the sealing cap from the Luer-lock connector. Manual cleaning

•• For cleaning the areas indicated by arrows, use cleaning brush A0451 and cleaning pistol O0190. •• To clean internal parts, use cleaning pistol O0190. •• Clean the outside and inside of the retractor thoroughly. Automatic cleaning •• Attach the male Luer-lock connector in the machine to the retractor’s Luer­lock connector. •• Use the adapter and the tube for flushing the instrument in order to remove all blood an tissue residues. 17

Reprocessing

7.2 Maintenance Lubrication

•• Lubricate the areas indicated by arrows. •• Use only Olympus A0273. Apply lubricant sparingly. •• Move all parts when lubricating. Sealing cap

•• If damaged or lost, replace the sealing cap with the A0400 sealing cap.

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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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© Copyright 2017 Olympus Winter & Ibe GmbH