COMPACT CYSTOSCOPE, OP TELESCOPE Instructions for Use

Contents 1 General information... 5 1.1 Upon delivery... 6 1.2 Manufacturer... 7 2 Terminology... 8 3 Technical data... 10 4 Compatible components... 11 5 Before use... 12 5.1 Inspection and testing... 12 6 Use... 13 6.1 Preparation... 13 6.2 Procedure... 15 6.3 After use... 19 7 Reprocessing... 20 7.1 Cleaning... 21 8 Sterilization... 22 9 Repair... 24

General information

1 General information Intended use A37025A OP telescope for use in percutaneous nephroscopy and pediatric cystoscopy. A37026A, A37027A Compact cystoscope for use in cystoscopy in pediatric applications. WA37025B Adapter for use as a meatus stopper in cystoscopy in pediatric 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 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 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 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 •• Instrument tray A05961A •• Sealing caps A0387 •• Instruction manual Contents WA37025B •• Adapter •• Instruction manual Contents A37026A •• Compact cystoscope •• Instrument tray A05961A •• Sealing caps A0387 •• Instruction manual Contents A37027A •• Compact cystoscope •• Instrument tray A05961A •• Sealing caps A0387 •• Instruction manual Unpacking •• Remove the instrument from the packaging. Do not use the packaging for routine storage. •• Open the instrument tray. 6

General information •• Remove the transport safeguard from the telescope’s proximal end. •• Remove the telescope from the instrument tray.

1.2 Manufacturer Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg Germany

7

Terminology

2 Terminology OP telescope A37025A

1) 2) 3) 4) 5) 6)

Distal end Locking cone Light-guide connector Finger rest Instrument port Irrigation port

Compact cystoscope A37026A

1) 2) 3) 4) 8

Distal end Light-guide connector Finger rest Instrument port

Terminology 5) Irrigation port Compact cystoscope A37027A

1) 2) 3) 4) 5)

Distal end Light-guide connector Finger rest Instrument port Irrigation port

9

Technical data

3 Technical data Size A37025A... 9.5/10.7 Fr. A37026A... 6.4/7.9 Fr. A37027A... 6.4/7.9 Fr. Length A37025A... 220 mm A37026A... 160 mm A37027A... 160 mm Working channel A37025A... 7.5 Fr. A37026A... 4.2 Fr. A37027A... 4.2 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.

A0460 O0332

A03200A A3290 AR-T10

MH-999E A37025A A37026A A37027A

A0387

A37022A A37025A

6 Fr./6 Ch.

WA37025B

A37026A A37027A 3.5 Fr./3,5 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. CAUTION! Risk of damaging the instrument This product is a precise optical device. Make sure that this product is handled with extreme care.

5.1 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 •• Hold the OP telescope’s or compact cystoscope’s distal end into a glass filled with sterile water. •• Observe an object at a distance of approximately 10-40 mm from the objective lens. The object must be clearly visible through the OP telescope/ compact cystoscope. Damaged product If the product is damaged or does not function properly, contact an Olympus representative or an authorized service center.

12

Use

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

6.1 Preparation Light-guide cable

•• Only when using A03200A: Remove the light-guide adapters from the telescope. •• 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.

13

Use Adapters on the light-guide connector

A0460 O0332

The nested light-guide adapters allow the telescope to be connected to light-guide cables of various manufacturers. If using a non-Olympus lightguide 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 excellent color reproduction. Connect the irrigation tubing

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

14

Use Connect the adapter to the A37025A OP-telescope (only for cystoscopic applications)

•• If desired, connect the adapter WA37025B to the OP-telescope.

6.2 Procedure Light source

•• Turn on the light source. Cystoscopy

•• Apply a medical-grade, water soluble lubricant to the OP telescope or compact cystoscope. 15

Use •• 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. 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.

16

Use 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.

17

Use Introduce a surgical instrument

•• Select a compatible flexible surgical instrument. •• In the case of 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 on the endoscopic picture. 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 the visual field can no longer be cleared we recommend using pressure systems (pressure cuff, roller pump, syringes). Procedure •• Perform the procedure.

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Use

6.3 After use Remove the surgical instrument •• In the case of 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 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 Olympus Endoscopy System Guide. 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 System Guide Endoscopy. + compatible − incompatible

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Reprocessing A37025A, A37026A, A37027A

WA37025B

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

+

+

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

7.1 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

8 Sterilization Instrument tray A05961A

•• Open the instrument tray.

•• Insert the instrument into the instrument tray as shown in the illustration. •• When loading the instrument tray, press the instrument into the notches of the silicone bars as shown in the illustration.

•• Close the instrument tray.

•• Before sterilization, seal the instrument tray in packaging appropriate for sterilization according to your hospital’s protocol. 22