Compact Cystoscope Instructions

General Information

A37025A

A37026A, A37027A, WS1588/1

WA37025B

Intended use. OP telescope for use in percutaneous nephroscopy and pediatric cystoscopy. Compact cystoscopes for use in cystoscopy in pediatric applications. Adapter for use as a meatus stopper in cystoscopy in pediatric applications. Do not use these products for any purpose other than their intended use. Medical use. These products are to be used only in a medical facility by trained medical personnel.

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NOTE! Instruction manual set. The complete instruction manual set for these products consists of this product-specific instruction manual (delivered together with the product) and the system-related instruction manual, entitled “Olympus Endoscopy System Guide” (supplied separately). 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 Olympus Endoscopy System Guide 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.

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0197

A37025A A37026A A37027A WS1588/1

WA37025B

Medical Device Directive (Europe). These products comply with the requirements of Directive 93/42/EEC concerning medical devices.

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 A37025A. • OP telescope A37025A • Instrument tray A05961A • Sealing caps A0387 • Instruction manual

Contents WA37025B. • Adapter • Instruction manual

Contents A37026A. • Compact cystoscope A37026A • Instrument tray A05961A • Sealing caps A0387 • Instruction manual

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Contents WS1588/1. • Compact cystoscope WS1588/1 • Instruction manual

Contents A37027A. • Compact cystoscope A37027A • Instrument tray A05961A • Sealing caps A0387 • Instruction manual

Unpacking (not for WS1588/1). • Remove the instrument from the packaging. Do not use the packaging for routine storage. • Open the instrument tray. • Remove the transport safeguard from the telescope’s proximal end. • Remove the telescope from the instrument tray. Unpacking (only for WS1588/1). • Remove the instrument from the packaging. Do not use the packaging for routine storage.

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Terminology

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OP telescope A37025A. ➀ Distal end ➁ Locking cone ➂ Light-guide connector ➃ Finger rest ➄ Irrigation port ➅ Instrument port

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Compact cystoscope A37026A, WS1588/1. ➀ Distal end ➁ Light-guide connector ➂ Finger rest ➃ Irrigation port ➄ Instrument port

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Compact cystoscope A37027A. ➀ Distal end ➁ Light-guide connector ➂ Finger rest ➃ Irrigation port ➄ Instrument port

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Technical Data

Cat.No.

Size Length Working [Fr.] [mm] channel [Fr.]

A37025A 9.5/10.7 A37026A 6.4/7.9 A37027A 6.4/7.9 WS1588/1 8.0/9.8

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220 160 160 160

7.5 4.2 4.2 5.5

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.

A03200A A3290 WA03200A

A37025A A37026A A37027A WS1588/1

MH-999E

AR-T10

A0460 O0332

A0387

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A37022A (S-1419/1)

A37025A

6 Fr. A37025A

A37025A

WA37025B

3.5 Fr. A37026A A37027A

5.5 Fr. WS1588/1

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Before Use

WARNING! Infection control risk. Properly reprocess the product before the first and each subsequent use, following the instructions in this manual and in the Olympus Endoscopy System Guide. Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel. CAUTION! Risk of damaging the instrument. This product is a precision optical device. Make sure that this product is handled with extreme care.

Inspection and Testing Inspecting the product. Visually inspect the product: • Make sure that it has no corrosion, dents or scratches. • Check all stopcocks for easy operability. • Make sure that the sealing caps are not damaged. Test image quality. • Place the OP telescope’s or compact cystoscope's distal end in a glass filled with sterile water. • Observe an object approximately 10 - 40 mm from the objective lens. The object must be clearly visible through the OP telescope/ compact cystoscope.

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Damaged product. If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center.

CAUTION! Wear (for sealing caps). When used as intended, this product is subject to wear, depending on the intensity of use. If a product has externally visible defects, contact the responsible Olympus representative at once. Later guarantee claims are forfeited. Any guarantee claims are void by previous use. Replace if necessary. If the instrument is damaged or does not function properly, replace it.

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Use

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

Preparation Light-guide cable. • Only when using A03200A: Remove the light-guide adapters. • Connect the telescope’s light-guide connector to a compatible Olympus light-guide cable. • Connect the light-guide cable to a compatible Olympus light source.

Adapters on the light-guide connector. The nested light-guide adapters allow the telescope to be connected to light-guide cables of various manufacturers. When using a non-Olympus light-guide cable, remove any inappropriate adapters. Olympus recommends the use of an Olympus light-guide cable and an Olympus light source. Only this combination will guarantee optimum illumination of the endoscopic image and color reproduction.

A0460 O0332

Connect the irrigation tubing. • Connect the irrigation tubing to the Luer-lock connectors.

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Connect the adapter to the A37025A OP-telescope (only for cystoscopic applications). • If desired, connect the adapter WA37025B to the OP-telescope.

Procedure Light source. • Turn on the light source.

Cystoscopy. • Apply a medical-grade, water-soluble lubricant to the OP telescope or compact cystoscope. • Carefully introduce the OP telescope or compact cystoscope under visual control into the urethra, advancing it into the urinary bladder.

Percutaneous nephroscopy. • Insert the OP telescope into the outer sheath. • Make sure that the outer sheath’s release button is aligned with the red dot on the OP telescope’s locking cone. • Press the OP telescope's locking cone into the outer sheath’s automatic locking ring. • Insert the outer sheath and OP telescope into the patient.

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WARNING! Injury and damage from thermal exposure. Light sources emit large amounts of energy. As a result: - The light-guide connector and the telescope’s distal end become extremely hot. - The light energy is concentrated in a relatively small area. Risks: - Thermal injury to the patient’s tissue (e.g. from prolonged exposure to the intense illumination in cavities with small lumens, or if the telescope’s distal end is placed into close proximity with the tissue). - Burns to the patient’s or user’s skin. - Burns or thermal damage to surgical equipment (e.g. surgical drapes, plastic materials, etc.). Countermeasures: - Avoid prolonged exposure to intense illumination. - Use the minimum level of illumination necessary to satisfactorily illuminate the target area. - Do not place the telescope’s distal end or the light-guide connector on the patient’s skin, on flammable materials, or on heat-sensitive materials. - Do not touch the telescope’s distal end or the light-guide connector. - Turn the light source off when detaching the telescope from the light-guide cable. - Allow the telescope and the lightguide cable to cool down after use. Introduce a surgical instrument. • Select a compatible flexible surgical instrument. • When using a surgical instrument with jaws, close the jaws. • Introduce the distal end of the surgical instrument through the sealing cap into the instrument port. • Open the instrument stopcock. • Advance the surgical instrument until its distal end becomes visible in the endoscopic image. 14

CAUTION! Risk of damaging the instrument. Do not close the instrument stopcock when a surgical instrument is inserted.

CAUTION! Reduced irrigation capacity. With the surgical instrument introduced, the irrigation capacity is reduced. If this reduction prevents the visual field from being cleared, we recommend using pressure systems (pressure cuff, roller pump, syringes).

Procedure. • Perform the procedure.

After Use Remove the surgical instrument. • When using a surgical instrument with jaws, close the jaws. • Remove the surgical instrument. Light source. • Turn off the light source. • Detach the light-guide cable from the OP telescope or compact cystoscope.

Reprocessing. • Immediately bring the product to the reprocessing area. • Reprocess the product following the instructions in this manual and in the Olympus Endoscopy System Guide.

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Reprocessing

WARNING! Infection control risk. Properly reprocess the product before the first and each subsequent use, following the instructions in this manual and in the Olympus Endoscopy System Guide. Improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel. Observe the following instrumentspecific instructions. Information in this section. The following reprocessing information supplements that in the Olympus Endoscopy System Guide. However, if the information given in this section differs from that in the Olympus Endoscopy System Guide, use the information given here. A37025A, A37026A A37027A, WA37025B, WS1588/1 ➀ Manual or automatic cleaning + ➁ Ultrasonic cleaning ➂ Disinfection or high-level disinfection + ➃ Gas sterilization (ETO) + ➄ Steam sterilization (autoclaving) +

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

CAUTION! Risk of damaging the instrument. Do not use incompatible reprocessing methods for this instrument. Instrument damage may occur.

Cleaning CAUTION! Risk of damaging the telescope. Always clean each telescope separately. Do not clean with other telescopes or other instruments.

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Sterilization Instrument tray A05961A. • Open the instrument tray. • Insert the instrument into the instrument tray as shown in the loading charts below. • When loading the instrument tray, press the instrument into the notches of the silicone bars as shown in the illustration at left. • Close the instrument tray. • Before sterilization, seal the instrument tray in packaging appropriate for sterilization according to your hospital’s protocol.

Instrument tray A05961A, loading charts. A37025A, A37026A, WS1588/1: top chart A37027A: bottom chart

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Repair

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Policy. Contact your Olympus representative or an authorized service center for repair and warranty information.

Repair guidelines. Follow the general repair guidelines in the Olympus Endoscopy System Guide.

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Manufactured by Kuehnstraße 61, 22045 Hamburg, Germany Phone: +49 40 669 66-0

7.049.776 7.0_12/08

© Copyright 2008 Olympus Winter & Ibe GmbH Printed in Germany