Fiber Hysteroscope and Fiber Cystoscope Instructions for Use

Richard Wolf reserves all rights in this document, in particular relating to reproduction, distribution, public communication and public dissemination. This document may not be modified, and texts and images must not be reproduced or translated without the express prior permission of Richard Wolf GmbH.

Copyright © RICHARD WOLF GmbH

Manufacturer RICHARD WOLF GmbH Pforzheimer Straße 32 75438 Knittlingen GERMANY Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300

www.richard-wolf.com

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Contents 1

General notes and instructions for use...

5

1.1

Safety instructions and levels of danger...

5

2

Technical description...

6

3

Intended use...

6

4

Indications and field of use ...

7

5

Contraindications and side effects ...

7

5.1

Contraindications...

7

5.2

Side effects...

7

6

Combinations ...

8

7

Illustration ...

9

7.1

Legend and identification ... 10

7.2

Symbols... 11

8

Application ... 12

8.1 8.1.1 8.1.2

Preparation ... 12 Connect flexible endoscope to system components. ... 12 Adapter (option)... 13

8.2 8.2.1 8.2.2 8.2.3 8.2.4 8.2.5 8.2.6 8.2.7 8.2.8

Additonal notes and instructions for use ... 14 Deflecting, locking and unlocking the instrument tip ... 15 Light... 16 Irrigation / suction ... 16 Electrical current... 17 Image quality ... 17 HF applications... 17 Laser application ... 19 Auxiliary instruments and endoscopic accessories ... 21

9

Checks... 22

9.1

Service life ... 22

9.2

Visual check ... 22

9.3 9.3.1 9.3.2

Function check ... 23 Adapter (option)... 23 Fiber Hysteroscope and Fiber Cystoscope ... 24

9.4 9.4.1

Leakage test ... 25 Carrying out a manual leakage test... 25

10

Reprocessing and maintenance ... 26

10.1

Reprocessing procedure ... 27

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5 10.2.6 10.2.7 10.2.8 10.2.9

Reprocessing sequence - Fiber Cystoscope and Fiber Hysteroscope ... 29 Machine reprocessing ... 32 Manual reprocessing ... 37 Checks and maintenance ... 42 Packaging... 42 Sterilization ... 45 Storage ... 46 Validation... 47 Reprocessing sequence - Leak tester (163.903) ... 47 Reprocessing in case of repair ... 48

10.3

Reprocessing sequence - Accessories ... 49

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10.3.1 10.3.2 10.3.3 10.3.4 10.3.5 10.3.6 10.3.7

Machine reprocessing ... 52 Manual reprocessing ... 54 Checks and maintenance ... 55 Packaging... 55 Sterilization ... 56 Storage ... 56 Validation... 56

11

Technical data and order data... 57

12

Spare parts and accessories ... 57

13

Operating, storage, transport and shipping conditions ... 61

13.1

Disposal of product, packaging material and accessories ... 61

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General notes and instructions for use The product must only be used as intended following the instruction manual by adequately trained and qualified medical personnel. Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned application and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the patient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing development, the product descriptions, illustrations and technical data may deviate slightly from the current state. For further information about our products please contact Richard Wolf GmbH or your representative.

1.1

Safety instructions and levels of danger WARNING This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in death or extremely serious injuries.

CAUTION This signal word is used to indicate a potentially dangerous situation. Not avoiding this situation can result in minor or moderate injury.

ATTENTION This signal word without warning sign is used to indicate a potential danger of material damage.

NOTE This signal word indicates additional useful information for the reader, such as hints for easier operation as well as cross references.

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2

Technical description Fiber Hysteroscope and Fiber Cystoscope comprising: n n

n n

n

Flexible insertion sheath Control housing with control lever and eyepiece – (control lever with locking brake on Fiber Cystoscopes 7305.001, 7305.006) Fiber image guide and cold-light connector Deflectable instrument tip – up: +130°/down: -160° on fiber hysteroscope 7325.122 – up: +210°/ab: -150° on fiber cystoscope 7305.001 – up: -210°/ab: +150° on fiber cystoscope 7305.006 Working channel with luer connector at 45°

Accessories n n

3

Adapter 7305.781 (optional) Adapter 7305.782 (optional)

Intended use The Fiber Hysteroscope and Fiber Cystoscope are used for visualizing body cavities and organs via natural passages. n

n

Adapter 7305.782 (optional) – is used for inserting auxiliary instruments through the working channel – is used for connecting suction and irrigation components Adapter 7305.781 (optional) – is used for inserting auxiliary instruments through the working channel – is used for connecting irrigation components

These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

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Indications and field of use For examination, diagnosis and / or therapy in conjunction with endoscopic accessories. The Fiber Hysteroscope and Fiber Cystoscope are used in the following medical disciplines:

Type

Designation

Medical discipline Surgery

Urology

Gynecology

X

X

ENT

7325.122

Fiber HYSTEROscope Ø 2.5MM WL 200MM

7305.001

Fiber CYSTOscope 15FR WL 400MM

X

X

X

X

7305.006

Fiber CYSTOscope 15FR WL 400MM

X

X

X

X

CAUTION Product failure during therapeutic use Interruption of therapeutic use n

In therapeutic applications a second product with the same features should be available as a backup.

5

Contraindications and side effects

5.1

Contraindications CJD

Creutzfeldt-Jakob Disease or a

vCJD

Variant of the Creutzfeldt-Jakob Disease

BSE

Bovine Spongiform Enzephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease)

TSE

Transmissible Spongiform Enzephalopathy

On the basis of the patient's general condition the attending physician must decide whether or not the planned application is possible. The laws and regulations valid in your country must be complied with. For further notes and instructions please refer to the latest medical literature. Contraindications directly related to the product are presently unknown.

5.2

Side effects No side effects are known if the system is used as intended.

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6

Combinations The Fiber Hysteroscope and Fiber Cystoscope are used in conjunction with n n n n n n

Light sources and fiber light cables Cameras and objective lenses HF surgical devices Suction and irrigation devices Lasers Endoscopic accessories, e.g. – flexible forceps – laser fibers – HF instruments – etc.

CAUTION Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n Combine the different products only if the intended use and the relevant technical data (working length, diameter, peak voltage, etc.) are the same. n Follow the instructions for use of the products used in combination with this product. n Observe the "Notes and instructions on HF applications", order no.: GA-S002 as well as the HF device manufacturer's instructions. The adapter, endoscope side, can be unscrewed and replaced by a suitable adapter to connect fiber light cables made by other manufacturers. For order data please refer to the latest catalog sheets.

Fig. 1 Use objective lenses with C-mount or RW-mount thread when working via the monitor. For order data please refer to the latest catalog sheet. n

For this, see GA-S022

Fig. 2

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Illustration A

7.4.1

3

2

7.4.3

7.4.2

7.3 7.4

7 7.4.4

8

7.2 7.1

9.3

10 11 12

1

9.2

6 4

5

#1

#3

#2 #5

#4

9.1

9

14 13.1 13

B 2

3

7.3

7

8 10

7.2 7.1

1

11 12

9.3

6 4

5

9

9.2 9.1

#1

14

#3

#2

13

#4

Fig. 3

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7.1

Legend and identification

Item

Designation

Item

Designation

A

Fiber Cystoscope 7305.001, 7305.006

B

Fiber Hysteroscope 7325.122

1

Working channel

8

Rubber cap

2

Objective lens

9

Adapter (option) wtih 2 luer connectors

3

Light exit

9.1

Locking ring

4

Instrument tip, controllable (deflectable)

9.2

Irrigation connector

5

Flexible instrument sheath

9.3

Luer sealing cap

6

Luer connector

10

Adapter, endoscope side (i.e. light cable adapter on the endoscope)

7

Adapter (option)

11

Focusing ring

7.1

Locking ring

12

Eyepiece

7.2

Supply and drain stopcocks

13

Control lever only for Fiber Cystoscope (A)

7.3

Instrument port stopcock

13.1

Brake (lock)

7.4

Stopcocks, with removable plug

14

Connector for leak test and pressure equalization

7.4.1

Stopcock with removable stopcock plug

7.4.2

Stopcock housing

7.4.3

Luer connector

7.4.4

Identification of capacity on stopcock housing/ stopcock plug

#

Other markings

#1

Product no.

#3

Serial Number

#2

CE 0124

#4

DataMatrix Code

#5

Identification on control lever L = Loose, B = Brake

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7.2

Symbols

Symbols

Designation Caution Follow the manual Product number Serial Number Lot code Manufacturer Manufacturing date Do not reuse! Number, amount

Do not use if package is damaged Keep away from sunlight!

Store in a dry place!

DataMatrix Code

CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products. Is only valid if the product and/or packaging is marked with this identification Products of category I, with the exception of sterile products and products with measuring function, are marked without the four-digit code number of the competent authority.The CE identification on the title page of these instructions for use relates exclusively to the Richard Wolf main product or, if serveal identical products are described, to the Richard Wolf product with the highest classification.The CE identification of the other Richard Wolf products and, if applicable, of products made by other manufacturers, described in these instructions for use results exclusively from the identification on the product and/or packaging.

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8

Application WARNING The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. n Immediately before and after use, check the products for damage, loose parts and completeness. Make sure that no missing instrument parts remain in the patient. n Do not use products which are damaged or incomplete or have loose parts.

8.1

Preparation ¯ Carry out a check ð Please refer to section 9 Checks ð Please refer to section 9.2 Visual check

8.1.1

Connect flexible endoscope to system components. b a

The fiber bundle diameter on the fiber light cable is identified by the colored coding ring (a) and the identification number (b) on the connector connecting to the endoscope. On the endoscope there is no code number or color coding ring.

10

1. Screw the adapter, endoscope side (i.e. the light cable to endoscope" adapter (10) firmly onto the endoscope. 2. Connect the fiber light cable to the cold-light connector and to a suitable light source.

Fig. 4

ATTENTION To achieve optimum light transmission, the fiber bundle diameters of the endoscope and fiber light cable must match. Possible consequences if there is a mismatch: n Fiber light cables with excessively large fiber bundle diameter (cross-section) cause ð excessive heating at the coupling point with the endoscope n Fiber light cables with excessively small fiber bundle diameter (cross-section) cause ð reduced light output

WARNING Intense heat due to high light energy! In the case of unfavorable combinations, temperature increases can occur at the coupling point or at the light exit point of the endoscope. Burns on the patient, user and others as well as damage to endoscope are possible. n Reduce the light output or choose a fiber light cable with suitable diameter.

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8.1.2

Adapter (option) Assembly is demonstrated and described by example of the adapter (7). 7.4.1

7

Installing the adapter (7)

8

1. Connect the stopcock plug (7.4.1). 2. Plug the rubber cap (8) onto the adapter (7). 3. Pull and hold the locking ring (7.1) as indicated by the arrow as far as it will go. 4. Engage the luer fitting (6) in the slot of the locking ring (7.1) and let go of locking ring (7.1). ð The locking ring (7.1) must return to its home position.

Fig. 5

6 7.1

Fig. 6 Connecting the supply and drain tubes 1. Connect the supply and drain tubes to the supply and drain stopcocks (7.2). 2. Open the supply and drain stopcocks (7.2). 3. Switch on the suction and irrigation system and check the suction and irrigation function. 4. Check the entire system for leak-tightness and free passage (patency).

7.2

Fig. 7 5. Carry out a function check. ð Please refer to section 9.3 Function check

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8.2

Additonal notes and instructions for use CAUTION Flexible endoscopes have limited strength! High forces or excessive mechanical loads can cause damage and impair the function. n Do not kink the flexible instrument sheath and do not bend to an excessively narrow radius (minimum 150 mm diameter).

CAUTION Do not block the deflectable instrument tip by outer influences (e.g. limited free space)! This may damage the controls. If the instrument tip is blocked, do not forcefully actuate the control lever. n Move the instrument tip to a position allowing control without applying any force.

CAUTION Danger of injury when removing the flexible endoscope with deflected and locked instrument tip! Inadvertent tissue damage as well as damage to the flexible endoscope is possible. n Release the brake on the control lever if applicable. n Move the instrument tip to straight ((0° position).

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8.2.1

Deflecting, locking and unlocking the instrument tip NOTE The straight position of the instrument tip (0° position) is indicated by the integrated snap-in position on the control lever.

¯ Actuate the control lever. Item Product no.

Direction

Deflection

Movement of control lever

A

up

210°

to proximal

down

150°

to distal

up

210°

to distal

down

150°

to proximal

up

130°

to proximal

down

160°

to distal

7305.001

7305.006

B

7325.122

up down to distal

to proximal

Fig. 8 Only for Fiber Cystoscope 7305.001, 7305.006 Locking (B = Brake)

(B)

13

The instrument tip can be locked in any deflected position. ¯ Push the control lever (13) in direction of arrow (B) as far as it will go. ð The instrument tip is locked in place. Unlocking (L = Loose) ¯ Move the control lever (13) in direction of arrow (L) to its home position.

13 (L)

Fig. 9

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8.2.2

Light

WARNING Intense heat due to high light energy! Danger of inadvertent tissue damage - due to insufficient distance between the light exit area and the tissue - due to soiling/contamination in the light exit area - When using high performance light sources n Do not touch the light exit area and avoid direct contact with the tissue. n Remove any soiling

WARNING Fire hazard! When placing the endoscope onto heat-sensitive flammable surfaces (dark drapes etc.) the high light energy at the light exit area of the endoscope can cause high temperatures or even ignition. n Store the endoscope in a safe place.

CAUTION Danger of injury due to dazzling! Danger of impaired vision. n Do not look into the light exit area of a flexible endoscope which is connected to the camera controller.

8.2.3

Irrigation / suction CAUTION Wrong irrigation fluid! Do not use high-conductivity irrigation fluid in monopolar HF applications! n Increased danger of patient leakage currents. n No function of the HF instrument. ð Depending on the application, the user must select a suitable low-conductivity irrigation fluid. ð Do not use saline (NaCl solution)!

CAUTION Danger of injuring the mucous membrane! If suction is carried out over a prolonged period of time with the instrument tip directly contacting the mucous membrane, hemorrhages of the mucous may occur. n Apply suction under visual control and at short intervals.

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8.2.4

Electrical current ATTENTION Use only products with type BF applied parts in conjuction with the flexible endoscope.

WARNING Danger of electric shock! Patient leakage currents can add up if the endoscopes are combined with other energetically operated endoscopic accessories. n Make sure that the combinations do not exceed the permissible patient leakage currents.

8.2.5

Image quality WARNING Increased risk potential if the image is blurred! Danger of injuring the patient. n Stop the intervention for safety reasons if the image is blurred. n Check the image quality of the endoscope before use. Please refer to section 9.3.2 Fiber Hysteroscope and Fiber Cystoscope

8.2.6

HF applications WARNING Danger of injury! Danger of injury if the HF instrument is not visible through the endoscope! Inadvertent tissue injury as well as damage to the distal end of the endoscope can occur. n Activate HF instruments only after the live part carrying HF current is fully visible through the scope and makes contact with the application area.

Fig. 10

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y

WARNING

HF sparking! Danger of injury if there is insufficient distance between the part of the HF product carrying high frequency and other conductive parts. During HF current activation, the parts of HF products carrying HF current must have a safe distance of at least 10 mm from other conductive parts.

Fig. 11

CAUTION

Excessive HF voltage! Danger of injury if the insulation of HF instruments is damaged! Exceeding the maximum recurring peak voltage of HF instruments in combination with HF surgical devices and/or using the wrong mode can destroy the insulation and cause leakage currents. This may result in thermal tissue damage of the patient, user and others. Use the HF instruments in combination with HF surgical devices only at a recurring peak voltage as indicated in the table, see section on Technical data and order data. A use with forced coagulation and spray coagulation above the specified values is not permissible! The HF instruments only lend themselves to short coagulations of tissue and smaller vessels (e.g. tubular structures, blood vessels).

CAUTION Thermal tissue injury! Using irrigation and HF current at the same time causes leakage currents which may lead to thermal tissue injury of the patient, user or others. n Activate the HF current only after having interrupted irrigation. n It is not permissible to use irrigation and HF current at the same time.

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WARNING Danger of burns and explosion hazard! The supply of highly concentrated oxygen during HF, plasma or laser applications will promote ignition or explosion of flammable or ignitable materials and endogenous gasses. Burns or injuries of the patient, user or others are possible. Avoid supplying highly concentrated oxygen during HF, plasma or laser applications. Make sure you follow the instruction manual of the HF, plasma and laser devices used in combination with this product.

CAUTION Wrong selection of HF output power! Injuries to the patient as well as damage to the product are possible. The power must be set based on the experience/training of the surgeon with regard to the current indication. To determine the optimum power setting we recommend starting at a low power setting.

8.2.7

Laser application NOTE When applying a laser make sure you follow the laser device manufacturer's instructions as well as the general regulations on the use of lasers. Wear the required personal protective equipment.

WARNING Eye injuries when used without filter attachment! Eye damage. n Use a suitable filter attachment on the eyepiece of the endoscope.

CAUTION Danger of injury! Do not work outside the scope's field of view! Inadvertent tissue damage as well as damage to the distal end of the instrument and to instrument parts are possible. n Activate the laser only after the tip of the laser fiber has become fully visible through the scope. n Activate the laser only after the pilot beam makes contact with the area to be treated.

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CAUTION High temperatures due to highly coherent laser beam! The heat generated by the laser beam reduces the strength of the instrument parts. n Do not direct the laser beam at instrument parts, in particular not at plastic parts. n Keep a safe distance.

CAUTION Danger of destroying the working channel by the sharp distal end of the laser fiber! The stronger (the stiffer) the laser fiber, the higher the risk that the sharp distal end of the laser fiber may destroy the working channel. n The laser fiber should therefore be inserted in the working channel and retracted from the working channel carefully and only while the instrument sheath is straight and the instrument tip is in straight position.

CAUTION Danger of destroying the flexible endoscope with a broken laser fiber! An angled instrument tip (small bending radius) increases the risk of a broken laser fiber, and even more so with increasing laser fiber diameter. If the laser fiber breaks within the instrument channel while the laser is active, this will immediately destroy the flexible endoscope. n In the latter case, switch off the laser energy immediately. n When using highly flexible laser fibers with a maximum permissible laser fiber diameter of 365 µm, the deflection range of the instrument tip is reduced.

ATTENTION Increased danger of laser fiber breakage if there is no protective coating or jacket! n We recommend removing only 1 mm of the laser fiber jacket at the distal tip.

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