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OLYMPUS

OLYMPUS Compact Cystoscope Instructions

Revision Not Listed

OLYMPUS Cystoscope Systems

20 Pages

INSTRUCTIONS  COMPACT CYSTOSCOPE, OP TELESCOPE A37025A, A37026A, A37027A, WA37025B, WS1588/1  Caution: Federal (USA) law restricts this device to sale by or on the order of a physician...  General Information  A37025A  A37026A, A37027A, WS1588/1  WA37025B  Intended use... P telescope for use in percutaneous nephroscopy and pediatric cystoscopy... ompact cystoscopes for use in cystoscopy in pediatric applications... dapter for use as a meatus stopper in cystoscopy in pediatric applications... o not use these products for any purpose other than their intended use... edical use... hese products are to be used only in a medical facility by trained medical personnel... ✓  +  NOTE! Instruction manual set... he 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)... mmediately contact an Olympus representative if either manual is missing or lost... eep the instruction manual set in a safe, accessible location... ARNING! Read all instruction manuals thoroughly... efore use, read this manual, the Olympus Endoscopy System Guide and the manuals for all other equipment which will be used during the procedure... n insufficient understanding of the dangers, warnings, cautions and information in these manuals can result in death, serious injury or equipment damage... 2
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OLYMPUS Compact Cystoscope Instructions WS1588-1 Aug 2012.pdf

Page 1

INSTRUCTIONS

COMPACT CYSTOSCOPE, OP TELESCOPE

A37025A, A37026A, A37027A, WA37025B, WS1588/1

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Page 2

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.

✓

+

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.

2

Page 3

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

3

Page 4

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.

4

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Terminology

➀

➁

➂

OP telescope A37025A.

➀ Distal end

➁ Locking cone

➂ Light-guide connector

➃ Finger rest

➄ Irrigation port

➅ Instrument port

➃

➃

➀

➁

➅

➄

Compact cystoscope A37026A,

WS1588/1.

➀ Distal end

➁ Light-guide connector

➂ Finger rest

➃ Irrigation port

➄ Instrument port

➂

➄

➃

➂

➀

➁

Compact cystoscope A37027A.

➀ Distal end

➁ Light-guide connector

➂ Finger rest

➃ Irrigation port

➄ Instrument port

➂

➂

➄

➃

➃

➄

5

Page 6

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

6

220

160

160

160

7.5

4.2

4.2

5.5

Page 7

7

Page 8

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

8

Page 9

A37022A

(S-1419/1)

A37025A

6 Fr.

A37025A

A37025A

WA37025B

3.5 Fr.

A37026A

A37027A

5.5 Fr.

WS1588/1

9

Page 10

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.

®

10

Damaged product. If the product is

damaged or does not function properly, contact an Olympus representative

or an authorized service center.

Page 11

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.

11

Page 12

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.

12

Page 13

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.

13

Page 14

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

Page 15

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.

15

Page 16

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.

➀

➁

➂

➃

➄

A37025A, A37026A

A37027A,

WA37025B,

WS1588/1

Manual or automatic cleaning

+

Ultrasonic cleaning

Disinfection or high-level disinfection

+

Gas sterilization (ETO)

+

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.

16

Page 17

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

17

Page 18

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 Olympus

Endoscopy System Guide.

18

Page 19

19

Page 20

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

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