S-Line Resectoscopes Instruction Manual

Important general notes and instructions for use Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, and that maintenance and repair are only car­ ried 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 products in accordance with the manual before every use and before return ship­ ment to protect the patient, user and third parties. Immediately upon receipt, check the product and its accessories for completeness and possible damage. Should the shipment give right to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments, the illustrations and technical data may deviate slightly. CAUTION : Federal law restricts this device to sale by or on the order of a physician.

Safety instructions and levels of danger Symbols

Level of danger

WARNING! Failure to observe can result in death or serious injury. CAUTION! Failure to observe can result in slight injury or damage to the product.

.

IMPORTANT! Failure to observe can result in damage to the product or surroundings.

.

NOTE! Tips for optimum use and other useful information. USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 MANUFACTURER [email protected] www.richardwolfusa.com

GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-300 [email protected] www.richard-wolf.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

[email protected] www.richard-wolf.be

0

Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05

[email protected] www.richard-wolf.com

[email protected] www.richard-wolf.com

GA-D 342

Contents 1

Technical description...

1

2 2.1 2.2 2.3 2.4 2.5

1 1 1 1 1

2.5.1 2.5.2 2.5.3 2.6 2.6.1 2.6.2 2.7

Intended use... Endoscope... Obturators... Working element... Electrodes... Resectoscope sheaths (continuous-irrigation double-sheath system) Models [ A ] [ B ] [ C ]... Resectoscope sheaths rotatable - Model [ A ]... Resectoscope sheaths not rotatable - Model [ B ]... Resectoscopes sheaths with rotatable irrigation ring - Model [ C ]... Resectoscope sheaths (intermittent irrigation) - Models [ D ] [ E ]... Resectoscope sheaths rotatable - Model [ D ]... Resectoscope sheaths - Model [ E ]... HF bipolar connection cable (14)...

2 2 2 2 2 2 3 3

3

Indications and field of use...

3

4

Contraindications...

3

5 5.1

Combinations... System overview for “S-line" S(a)line- Resectoscopes...

4 4

6 6.1

Illustration... 5 Resectoscope sheaths (continuous-irrigation double-sheath system) Models [ A ] [ B ] [ C ]... 5 Legend and identification... 6 Resectoscope sheaths (intermittent irrigation) - Models [ D ] [ E ]... 7 Legend and identification... 8 Obturators, working elements and electrodes... 9 Legend and identification... 10 Electrodes... 11 Legend and identification... 11

6.1.1 6.2 6.2.1 6.3 6.3.1 6.4 6.4.1 7 7.1 7.1.1 7.1.2 7.1.3 7.1.4 7.1.5 7.1.6 7.1.7 7.1.8 7.2 7.2.1 7.2.2 7.2.3 7.2.4 7.2.5

GA--D 342

Use... 13 Preparation... 13 Resectoscope sheaths - Models [ A ] [ D ]... 13 Inserting continuous-irrigation inner sheath (1) in continuous-irrigation outer sheath (2) Models [ A ] [ B ] [ C ]... 14 Inserting obturator (6) in resectoscope sheath - Models [ A ] - [ E ]... 14 Inserting obturator (6) in resectoscope sheath - Models [ A ] [ D ]... 15 Inserting endoscope (10) in viewing obturator (8) - Models [ A ] - [ E ]... 16 Inserting the electrode (13) into working element (11) (12) - Models [ A ] - [ E ]... 16 Inserting endoscope (10) in working element (11) (12) - Models [ A ] - [ E ]... 17 Inserting working element (11) (12) in continuous-irrigation inner sheath Models [ A ] - [ E ]... 18 Additional notes and instructions for use... 18 Resectoscope sheaths (continuous-irrigation double-sheath system) Models [ A ] [ B ] [ C ]... 18 Resectoscope (intermittent irrigation) - Models [ D ] [ E ]... 18 S(a)line Resectoscope - Models [ D ] [ E ]... 19 Irrigation fluid... 21 HF applications... 21

I

8 8.1 8.1.1 8.1.2 8.1.3 8.2 8.2.1

Checks... Visual check... HF bipolar connection cable (14)... S(a)line Resectoscope - Models [ A ] - [ E ]... Electrodes... Function check... S(a)line Resectoscope - Models [ A ] - [ E ]...

23 23 23 23 23 24 24

9 9.1 9.2 9.3 9.3.1

Reprocessing and maintenance... Dilation obturator (9)... Electrodes... Disassembly before cleaning... Resectoscope sheaths (continuous-irrigation double-sheath system) Models [ A ] [ B ] [ C ]... Resectoscope sheaths (intermittent irrigation) - Models [ D ] [ E ]... Manual reprocessing... HF bipolar connection cable (14)... Machine reprocessing... HF bipolar connection cable (14)... Checks... Assembly before sterilization... Resectoscope sheaths (continuous-irrigation double-sheath system) Models [ A ] [ B ] [ C ]... Resectoscope sheaths (intermittent irrigation) - Models [ D ] [ E ]... Dilation obturator (9) - Models [ A ] [ D ]... Sterilization... Steam sterilization... Gas sterilization...

25 25 25 25

Technical data and order data... Electrodes for S(a)line Resectoscopes 8680.xxx, Endoscope 4 mm, 30° / 25° / 12° / 0°... Multi-use electrodes, reprocessable... Single-use electrodes, sterile...

31

9.3.2 9.4 9.4.1 9.5 9.5.1 9.6 9.7 9.7.1 9.7.2 9.7.3 9.8 9.8.1 9.8.2 10 10.1 10.1.1 10.1.2 11 11.1 11.2

25 26 28 28 28 28 28 29 29 29 30 30 30 30

31 31 31

11.3

Spare parts and accessories... S(a)line Resectoscopes - Models [ A ] - [ E ]... S(a)line Resectoscopes (continuous-irrigation double-sheath system) Models [ A ] [ B ] [ C ]... S(a)line Resectoscopes (intermittent irrigation) - Models [ D ] [ E ]...

32 32

12 12.1

Operating, storage, transport and shipping conditions... 33 Disposal of product, packaging material and accessories... 33

13

Literature... 34

14

Warranty and Customer Service... 35

II

GA--D 342

32 33

1

Technical description

S(a)line Resectoscopes consist of: Z Endoscope Z Resectoscope sheaths with obturators Z Working element Z Electrodes ' Multi-use electrodes, reprocessable ' Single-use electrodes, sterile Z HF bipolar connection cables

2

Intended use

S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can be used for monopolar resection if necessary. This requires the following: ' Correct selection of the irrigation medium ' Correct positioning of the neutral electrode ' Correct power settings on the HF surgical device. For further notes and instructions please see the instruction manuals. ' Notes on HF applications GA-S 002 ' “E-LINE” Resectoscopes GA-D 345

2.1

Endoscope for visualization inside the patient via natural accesses

2.2

Obturators Obturators are used for atraumatic insertion of the resectoscope sheath into the urethra. Z Obturator with movable head. ' adapts to the anatomical situation in the upper urethra Z Viewing obturator ' for holding and fixing the endoscope ' for atraumatic insertion of the resectoscope sheath under visual control Z Dilation obturator ' The dilation obturator is used for atraumatic insertion of the resectoscope sheath in the urethra by dilating the distally flexible obturator shank via the inclinable handle.

2.3

Working element The working element serves to hold and fix the endoscope and is used for con­ trolled insertion of the electrode into the operating area under visual control.

2.4

Electrodes

for ablating, transecting, severing/resecting, coagulating and vaporizing soft tissue. The electrodes differ regarding their use / reprocessing / reusability: Z Multi-use electrodes, reprocessable ' Application: Bipolar ' Identification feature: the product numbers start with “8" example: 8622131 Z Single-use electrodes, sterile ' Application: Bipolar ' Identification feature: the product numbers start with “4" example: 4622.1313

GA--D 342

1

2.5

Resectoscope sheaths (continuous-irrigation double-sheath system) - Models

2.5.1

Resectoscope sheaths rotatable - Model

A

B

C

A

Z Rotatable adapter ' for holding and automatic fixing of the working element ' provides a rotatable connection between the continuous-irrigation innersheath and the working element with endoscope and electrode Z Continuous irrigation inner sheath ' provides continuous irrigation fluid supply Z Continuous irrigation outer sheath ' for holding and automatic fixing of the continuous-irrigation inner sheath ' for drainage or aspiration of irrigation fluid 2.5.2

B

Resectoscope sheaths not rotatable - Model

Z Continuous irrigation inner sheath ' for holding and automatic fixing of the working element ' provides continuous irrigation fluid supply Z Continuous irrigation outer sheath ' for holding and automatic fixing of the continuous-irrigation inner sheath ' for drainage or aspiration of irrigation fluid 2.5.3

Resectoscopes sheaths with rotatable irrigation ring - Model

C

Z Continuous irrigation inner sheath ' for holding and automatic fixing of the working element ' provides continuous irrigation fluid supply ' for drainage or aspiration of irrigation fluid Z Continuous irrigation outer sheath ' for holding and automatic fixing of the continuous-irrigation inner sheath

2.6

Resectoscope sheaths (intermittent irrigation) - Models

2.6.1

Resectoscope sheaths rotatable - Model

D

E

D

Z D1 - Resectoscope sheath with luer connector Z D2 - Resectoscope sheath with irrigation stopcock Z D3 - Resectoscope sheath with central stopcock Z Rotatable adapter (D1, D2, D3) ' for holding and automatic fixing of the working element ' provides a rotatable connection between the resectoscope sheath and thewor­ king element with endoscope and electrode Z Resectoscope sheath (D1, D2) ' for holding and automatic fixing of the working element ' provides continuous irrigation fluid supply Z Resectoscope sheath (D3) ' for continuous irrigation fluid supply (stopcock plug in the “IN” position) ' for maintaining the irrigation fluid once the bladder capacity has been rea­ ched (stopcock plug in the “0“ position) ' for drainage or aspiration of irrigation fluid (stopcock plug in the “OUT” position)

2

GA--D 342

2.6.2

Resectoscope sheaths - Model

E

Z E1 - resectoscope sheath with rotatable irrigation ring Z E2 - resectoscope sheath with permanent irrigation stopcock Z E3 - resectoscope sheath with central stopcock Z Resectoscope sheath (E1,E2) ' for holding and automatic fixing of the working element ' provides continuous irrigation fluid supply Z Resectoscope sheath (E3) ' for continuous irrigation fluid supply (stopcock plug in the “IN” position) ' for maintaining the irrigation fluid once the bladder capacity has been rea­ ched (stopcock plug in the “0“ position) ' for drainage or aspiration of irrigation fluid (stopcock plug in the “OUT” posi­ tion)

2.7

HF bipolar connection cable (14) for the connection of S(a)line Resectoscopes to HF surgical devices with bipolar connector for TUR/TUVP application.

3

Indications and field of use

For examination, diagnosis and/or therapy in conjunction with endoscopic ac­ cessories in the various medical disciplines, such as Z Urology Z Gynecology Z Surgery Application: Z Transurethral resection of the prostate (TURP) Z Transurethral resection of bladder tumors (TURB) Z Transurethral vaporization of the prostate (TUVP) Z Adenomas Z Myoma resection Z Soft tissue tumors Z Endometrium ablation Z Slitting of the neck of the bladder and incision of the prostate

. 4

Contraindications

GA--D 342

NOTE! We recommend reading relevant literature regarding the planned use (see also section 13 “Literature”). Contraindications directly related to the product are currently unknown. On the basis of the patient's general condition the surgeon in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature.

3

5

Combinations

S(a)line Resectoscopes are used in conjunction with: Z Light sources and fiber light cables Z HF surgical devices with bipolar connection for TUR/TUVP applications Z Pumps for irrigation or suction Z Endoscopic accessories

CAUTION! Do not combine products incorrectly! Injuries to the patient, user or others as well as damage to the product are possible. Joint use of the different products is only allowed if the intended uses and relevant technical data (such as working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product. Also follow the “Instructions on HF Applications“, order no.: GA-S 002 as well as the HF device manufacturer's instructions. CAUTION! Do not use electrodes made by other manufacturers.

5.1

System overview for

“S-line” S(a)line- Resectoscopes For S(a)line Resectoscopes (continuous-irrigation double-sheath system) / (inter­ mittent irrigation) please see brochure BB-D 342.

4

GA--D 342

6

Illustration

6.1

Resectoscope sheaths (continuous-irrigation double-sheath system) - Models

A

1.3 1.1

3.2

1.2

3.1

A

B

C

3

*

3.3 3.4

9

1

# 3.5

2.1

2.2

2.3

2

#

2.4 2.5 #

2.6

B 6, 7, 8, 10, 11, 12

1

2 #

C

1.6 1.4

1 1.5 1.7

2 Fig. 1

GA--D 342

5

Legend and identification

6.1.1

Resectoscope Models Item

Designation

A

B

rotatable

not rotatable

1

Continuous irrigation inner sheath

J

J

J

1.1

Sheath

J

J

J

1.2

Recess

J

J

J

1.3

Irrigation stopcock, disassemblable

J

J

J

1.4

Threaded ring

j

j

J

1.5

Irrigation ring with irrigation and drain stop­ cock

j

j

J

1.6

Sealing ring

j

j

J

1.7

Drain stopcock, disassemblable

j

j

J

2

Continuous irrigation outer sheath

J

J

J

2.1

Suction holes

J

J

J

2.2

Sheath

J

J

J

2.3

Saddle with color coding

J

J

J

2.4

Pin

J

J

J

2.5

Locking mechanism

J

J

J

2.6

Drain stopcock, disassemblable

J

J

j

3

Rotatable connector

J

j

j

3.1

QUAD lip seal

J

j

j

3.2

Locking collar

J

j

j

3.3

Rotatable connector

J

j

j

3.4

Locking mechanism

J

J

J

3.5

Tab with color coding

J

J

J

*

Fr. indication

J

J

J

#

Product no.

J

J

J

J

6

C with rotatable irrigation ring

= applicable

j

= not applicable

GA--D 342

6.2

Resectoscope sheaths (intermittent irrigation) - Models

D

E

1.3

D

1.1

1.2

D1 #

1.4

1

3.1

3

*

3.2

3.3 3.4

9

D2 #

1.5

4.4 4.3

4

D3 4.2

3.5

#

4.1

1.6

1

6, 7, 8, 10, 11, 12

1.11

E

1.8 1.9

*

E1

1.7 #

1.10

*

E2 # 5.3

* 5.4

E3 5.2 5.1 5.5

#

5

Fig. 2

GA--D 342

7

Legend and identification

6.2.1

Resectoscope Models Item

D

Designation

E

rotatable D1

D2

D3

E1

E2

E3

1

Resectoscope sheath

J

J

J

J

J

J

1.1

Sheath tube

J

J

J

J

J

J

1.2

Thrust washer with color coding

J

J

J

j

j

j

1.3

Luer connector

J

j

j

J

j

j

1.4

Irrigation stopcock, disassemblable

j

J

j

j

J

j

1.5

“IN" connector

j

j

J

j

j

J

1.6

“OUT" connector

j

j

J

j

j

J

1.7

Locking mechanism

j

j

j

J

J

j

1.8

Tab with color coding

j

j

j

J

J

j

1.9

Threaded ring

j

j

j

J

j

j

1.10

Irrigation ring with luer fitting

j

j

j

J

j

j

1.11

Sealing ring

j

j

j

J

j

j

2

Not assigned

j

j

j

j

j

j

3

Rotatable connector

J

J

J

j

j

j

3.1

QUAD lip seal

J

J

J

j

j

j

3.2

Locking collar

J

J

J

j

j

j

3.3

Rotatable connector

J

J

J

j

j

j

3.4

Locking mechanism

J

J

J

j

j

j

3.5

Tab with color coding

J

J

J

j

j

j

4

Stopcock plug

j

j

J

j

j

J

4.1

Stopcock plug

j

j

J

j

j

J

4.2

Stopcock toggle

j

j

J

j

j

J

4.3

O-ring (outside)

j

j

J

j

j

J

4.4

O-ring (face)

j

j

J

j

j

J

5

Locking element

j

j

j

j

j

J

5.1

Locking collar

j

j

j

j

j

J

5.2

Sleeve

j

j

j

j

j

J

5.3

O-ring

j

j

j

j

j

J

5.4

Locking mechanism

j

j

j

j

j

J

5.5

Tab with color coding

j

j

j

j

j

J

*

Fr. indication

J

J

#

Product no.

J

J

D1 = with luer fitting D2 = with irrigation stopcock D3 = with central stopcock E1 = with rotatable irrigation ring E2 = with permanent irrigation stopcock E3 = with central stopcock J

8

= applicable

j

= not applicable

GA--D 342

6.3

Obturators, working elements and electrodes

6

10

6.1

#

7 1

8.1

8

8.2 W

9.1

9

V

9.2

#

#

11.1

X Z

11

Y

11.2 # 13.1 #

13

13.2

13.3 #

14.3

12.1

12 14 14.1 gray 12.2

Fig. 3

14.2 black

GA--D 342

9

6.3.1

Legend and identification Item

Designation

Item

Designation

6

Obturator

13

Electrodes for Endoscope, direction of view 0

6.1

Handle with color coding

13.1

- Multi-use electrodes, reprocessable

- Single-use electrodes, sterile for Endoscope, direction of view 30/25/12 7

Obturator with movable head

13.2

- Multi-use electrodes, reprocessable

- Single-use electrodes, sterile 8

for Endoscope, direction of view 0

Viewing obturator

- Single-use electrodes 13.3

8.1

Clamping lever

Sterile vaporization electrodes

for Endoscope, direction of view 30/25/12 - Single-use electrodes

Sterile vaporization electrodes

10

HF bipolar connection cable

8.2

Locking ring

14

9

Dilation obturator

14.1

Instrument connector, gray for connection to neutral PIN

9.1

Flexible obturator shank

14.2

Instrument connector, black for connection to electrode lock

9.2

Inclinable handle with color coding

14.3

Device connector for connection to HF surgical device

10

Endoscope

11

Working element, active cutting action

11.1

Cutting is effected against spring action Open handle

V

HF connector

11.2

Cutting is effected against spring action Closed handle

W

Neutral pin

12

Working element, passive cutting action

X

Electrode lock

12.1

Cutting is effected by spring action Open handle

Y

Button

12.2

Cutting is effected by spring action Closed handle

Z

Receptacle

#

Product no.

- made by ERBE - made by MARTIN (not shown - see section 11.1)

GA--D 342

6.4

Electrodes

30 / 25/ 12

F

G

H

K

16 15

17

0

18

19

20

30 / 25/ 12

I F G H I K

F H K

30 / 25/ 12

0

Fig. 4 6.4.1

Legend and identification Item

Designation Electrode structure

Item

Designation Electrode structure

15

Electrode head

18

Guide tube

16

Distal insulation (fork)

19

Proximal insulation (stem)

Guide nose

20

Contact end Product no.

17

' with guide nose below the guide tube = 30 / 25 / 12 Endoscope above the guide tube = 0 Endoscope ' without guide nose = 30 / 25 / 12 Endoscope and only in conjunction with continuous irrigation resectoscope sheath, rotatable 24.5 Fr.

F-K

' on electrode Multi-use electrodes, reprocessable ' on sterile packaging Single-use electrodes, sterile

Multi-use electrodes, reprocessable Single-use electrodes, sterile

F/I

Electrode shapes Cutting electrode

G/I

Hook electrode

H/I

Coagulation electrode

GA--D 342

#

K

Electrode shapes Vaporization electrode

11

Symbol

Designation Caution, consult ACCOMPANYING DOCUMENTS!

REF

Order no. Lot designation LOT identification of HF bipolar connection cable 8108.232 / 8108.252 The year is indicated in the center of the circle, the arrow showing the month.

SN

Serial no. Unsterile

Manufacturing date Quantity Use--by date

Do not reuse. Sterilized with ethylene oxide Protect from heat !

<60

Protect from moisture ! Identification in conformity with medical devices directive 93/42/EEC is only valid if the product and/ or packaging is marked with this symbol. Products of class IIa and above as well as sterile products or products with measuring function of class I are additionally identified with the code no. of the notified body (0124).

12

GA--D 342

7

Use WARNING! Do not reprocess disposable items! The service life of products marked "disposable", i.e. for single use only, has been designed for only one use in or on a single patient. If disposable items are reprocessed to be used again, a deterioration of the pro­ duct quality cannot be excluded, endangering the patient, user and third parties. Possible dangers and risk factors are ' strength problems ' damage to the product ' considerable impairment of the product function ' greately increased risk of infection ' biocompatibility problems If a disposable item is reprocessed, the product responsibility lies with the user or reprocessor. In this case the manufacturer can no longer guarantee product safety and per­ formance. CAUTION! The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

. 7.1

IMPORTANT! Bipolar resection in physiological saline (0.9% NaCl solution) for TUR/TUVP appli­ cations is only possible with an HF surgical device with bipolar connection.

Preparation The following preparatory measures are required for the S(a)line Resectoscopes concerned: Z Check assembly: see section 9.7 Z Carry out a check: sections 8 and 8.1

7.1.1

Resectoscope sheaths - Models

A

D

Resectoscope sheaths rotatable (A) (D1) (D2) (D3)

X

Fig. 5

1

3.1

3.3

Z Unscrew the rotatable connector (3.3) and check that a QUAD lip seal (3.1) is installed. Z Check the QUAD lip seal (3.1) for correct position. ' The sealing lip (x) must be on the side of the resectoscope sheath (1). Z Firmly screw on the rotatable connector (3.3).

Fig. 5

GA--D 342

13

7.1.2

Inserting continuous-irrigation inner sheath (1) in continuous-irrigation outer sheath (2) - Models

A

B

C

Fig. 6 Locking: Z Insert the continuous irrigation inner sheath (1) in the continuous irrigation outer sheath (2) in such a way that the recess (1.2) and the pins (2.4) are aligned. Push together until the locking mechanism (2.5) engages automatically. Unlocking: Z Push saddle (2.3) of continuous-irrigation outer sheath (2) in the direction indi­ cated by the arrow and remove continuous-irrigation inner sheath (1). 2.3

1.2

2.5 2.4

Fig. 6

7.1.3

2

Inserting obturator (6) in resectoscope sheath - Models

1

A

- E

Fig. 7 Locking: Z Insert obturator (6) in resectoscope sheath (1) in such a way that the groove (a) and the pin (b) are aligned. Push together until the locking mechanism (3.4) engages automatically.

.

NOTE! If the locking mechanism (3.4) won't engage, push the tab (3.5) as far as it will go and repeat the procedure. Unlocking: Z Push the tab (3.5) and remove the obturator (6). a b 3.5

Fig. 7

14

3.4

6

GA--D 342

7.1.4

Inserting obturator (6) in resectoscope sheath - Models

A

D

Fig. 8

9

.

IMPORTANT! Insert the dilation obturator (9) only horizontally into the resectoscope sheath and withdraw it in the same way.

Locking and unlocking: Z same procedure as described under section 7.1.3.

Fig. 8 Fig. 9 Dilating the flexible obturator shank (9.1) Z Angle the inclinable handle (9.2) up to the stop position (90 position). ' The handle (9.2) is locked in the end position.

.

IMPORTANT! The flexible obturator shank is only conically dilated creating an atraumatic transition between the obturator tip and the end of the sheath when the handle is in the end position.

Z Check dilation of obturator shank (9.1). Z Do not use the dilation obturator (9) ' if it is not possible to move the inclinable handle (9.2) to its end position. ' if the flexible obturator is damaged (e.g. cracked).

9

9.1

9.2

Fig. 9

GA--D 342

15

7.1.5

Inserting endoscope (10) in viewing obturator (8) - Models

A

- E

Fig. 10 L The clamping lever (8.1) must be in position “I". Locking: Z Insert endoscope (10) in viewing obturator (8). ' The pin (c) engages in the groove (d). Z Turn locking lever (8.1) to position "II". ' Both components are locked together. L The clamping lever (8.1) must be in position “II". Unlocking: Z Turn locking lever (8.1) to position "I". ' The locking mechanism is unlocked. Z Remove endoscope (10). 8.1 I

Fig. 10

7.1.6

I

8

Inserting the electrode (13) into working element (11) (12) - Models

.

16

II c d

II

10

A -

E

IMPORTANT! Check electrodes and endoscope for compatibility. Compatibility information for disposable electrodes is printed on the sterile packa­ ging, and for reprocessable electrodes on the electrode itself. Additional feature indicating compatibility: ' Guide nose below the guide tube: Electrode is compatible with endoscope, viewing direction 30 / 25 / 12 ' Guide nose above the guide tube: Electrode is compatible with endoscope, viewing direction 0 ' without guide nose: Electrode is compatible with endoscope, viewing direction 30 / 25 / 12 and only in conjunction with rotatable continuous-irrigation resectoscope sheath 24.5 Fr.

GA--D 342