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Instruction Manual
“E--LINE” Resectoscopes Continuous Irrigation Double Sheath 8655.xxx / 8656.xxx / 8658.xxx with Intermittent Irrigation 8654.xxxx / 8657.xxx / 8658.xxx / 8661.xxx / 8663.xxx / 8666.xxx / 8668.xxx
GA-D 345 / USA / 2011-11 V4.0 / ECO 2011-0484
(RW: 2011-11 V5.0 / PDI 11-5378)
Important general notes and instructions for use Ensure that this product is used only as intended and described in this instruction manual, by ad equately trained and qualified personnel, and that maintenance and repair are only 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. Prior to each use and return shipment, reprocess the product as specified in these instructions to protect the patient, user and third parties. Subject to technical changes! Due to the continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. 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] www.richard-wolf.com
[email protected] www.richard-wolf.be 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 [email protected] www.richard-wolf.com
0
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
GA-D 345
Contents 1
Technical Description...
1
2 2.1 2.2 2.3 2.4 2.5 2.5.1 2.5.2 2.5.3 2.6 2.6.1 2.6.2 2.6.3
Intended Use... Endoscope... Obturators... Working element... Electrodes... Resectoscope continuous-irrigation double-sheath system - Models (A) (B) (C)... Resectoscope, rotatable - Model (A)... Resectoscope, not rotatable - Model (B)... Resectoscopes with rotatable irrigation ring - Model (C)... Resectoscope with intermittent irrigation - Models (D) (E) (F)... Resectoscopes, rotatable - Model (D)... Resectoscope - Model (E)... Resectoscopes by Marberger - Model (F)...
1 1 1 1 1 2 2 2 2 3 3 3 3
3
Indications and Field of Use...
4
4
Contraindications...
4
5 5.1
Combinations... System overview for “E-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) (F)... 7 Legend and Identification... 8 Obturators, working elements and electrodes... 9 Legend and Identification... 10 Electrodes, reprocessable, single-use electrodes, sterile, EVAP electrodes... 11 Legend and Identification... 12
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 345
Use... 13 Preparation... 13 Resectoscope - 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) - (F)... 14 Inserting dilation obturator (9) in resectoscope sheath - Models (A) (D)... 15 Inserting endoscope (10) in viewing obturator (8) - Models (A) - (F)... 16 Inserting electrode (13) in working element (11) (12) - Models (A) - (F)... 16 Inserting endoscope (10) in working element (11) (12) - Models (A) - (F)... 17 Inserting working element (11) (12) in resectoscope sheath - Models (A) - (F)... 17 Additional notes and instructions for use... 18 Resectoscope continuous-irrigation double-sheath system - Models (A) (B) (C)... 18 Resectoscope with intermittent irrigation - Models (D) (E) (F)... 18 Resectoscope - Models (A) - (F)... 18 Irrigation fluid... 19 HF application... 19
I
8 8.1 8.1.1 8.1.2 8.2 8.2.1
Checks... Visual check... Resectoscope - Models (A) - (F)... Electrodes... Functional check... Resectoscope - Models (A) - (F)...
21 21 21 21 22 22
9 9.1 9.2 9.3 9.3.1 9.3.2 9.4 9.5 9.6 9.7 9.7.1 9.7.2 9.7.3 9.8 9.8.1 9.8.2
Reprocessing and maintenance... Dilation obturator (9)... Electrodes... Disassembly before cleaning... Resectoscope, continuous-irrigation double-sheath system - Models (A) (B) (C)... Resectoscope with intermittent irrigation - Models (D) (E) (F)... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Resectoscope, continuous-irrigation double-sheath system - Models (A) (B) (C)... Resectoscope with intermittent irrigation - Models (D) (B) (C)... Dilation obturator (9) - Models (A) (D)... Sterilization... Steam sterilization... Gas sterilization...
23 23 23 23 23 24 26 26 26 26 26 27 28 28 28 28
10 10.1 10.2 10.3 10.3.1 10.3.2 10.4 10.5 10.6 10.7 10.8 10.9 10.9.1 10.9.2 10.10
Technical data and order data... Electrodes for resectoscopes 8654.xxx, 4 mm endoscope, 30 / 25 / 12... Electrodes for resectoscopes 8661.xxx, endoscope 4 mm, 0... Electrodes for high-performance resectoscopes by Marberger, oval... Resectoscope 8654.xxx, endoscope 4 mm, 30 / 25 / 12... Resectoscope 8661.xxx, endoscope 4 mm, 0... Electrodes for resectoscopes 8656.xxx, endoscope 3.3 mm, 30 / 25... Electrodes for resectoscopes 8666.xxx, endoscope 3.3 mm, 0... Electrodes for resectoscopes 8668.xxx, endoscope 4 mm, 25, long sheath... EVAP electrodes, resectoscope 8654.xxx, endoscope 4 mm, 30 / 25 / 12... EVAP electrodes, resectoscope 8661.xxx, endoscope 4 mm, 5 / 0... EVAP electrodes for high-performance resectoscopes by Marberger, oval... Resectoscope 8654.xxx, endoscope 4 mm, 30 / 25 / 12... Resectoscope 8661.xxx, endoscope 4 mm, 5 / 0... EVAP electrodes for resectoscopes 8656.xxx, endoscope 3.3 mm, 30 / 25...
29 29 30 30 30 30 31 31 31 31 32 32 32 32 32
11 11.1 11.2
Spare parts and accessoriess... 33 Resectoscope, continuous-irrigation double-sheath system - Models (A) (B) (C)... 33 Resectoscope with intermittent irrigation - Models (D) (E) (F)... 33
12 12.1
Operating, storage, transport and shipping conditions... 34 Disposal of product, packaging material and accessories... 34
13
Warranty and Customer Service... 35
II
GA-D 345
1
Technical Description Resectoscopes are used in transuretheral resection of the prostate (TURP) and in transuretheral resection of bladder tumors (TURB).They consist of: Z Endoscope Z Resectoscope sheaths with obturators Z Working element Z Electrodes
2
Intended Use Resectoscopes are used for endoscopically controlled ablation of tissue.
2.1
Endoscope The endoscope is used for visualizing the inside of the patient via natural passages.
2.2
Obturators Obturators are used for atraumatic insertion of the resectoscope sheath into the urethra. Z Obturator with moveable 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 moveable handle.
2.3
Working element The working element serves to hold and fix the endoscope and the electrode and is used for controlled insertion of the electrode into the operating area under visual control.
2.4
Electrodes Electrodes are used for ablation (removal), severing, cutting and coagulating soft tissue. Z Electrodes, reprocessable / single--use electrodes, sterile ' for combined cutting and coagulation Z Electro--vaporization electrodes (EVAP) ' for combined cutting/vaporization and ablation The electrodes differ with regard to reprocessing / reusability: Z Electrodes, reprocessable ' Characteristic feature: The product numbers start with “8” Example: 8424.131 Z Single--use electrodes, sterile ' Characteristic feature: The product numbers start with “4” Example: 48424.1310
GA-D 345
1
A
B
C
2.5
Resectoscope continuous--irrigation double--sheath system -- Models
2.5.1
Resectoscope, rotatable -- Model Z Rotatable connector ' for holding and automatic fixing of the working element ' provides a rotatable connection between the continuous--irrigation inner sheath and the working element with endoscope and electrode
A
Z Continuous--irrigation inner sheath ' for continuous irrigation fluid supply Z Continuous--irrigation outer sheath ' for holding and automatic fixing of the continuous--irrigation inner sheath ' for draining or aspiration of irrigation fluid
B
Resectoscope, not rotatable -- Model Z Continuous--irrigation inner sheath ' for continuous irrigation fluid supply
2.5.2
Z Continuous--irrigation outer sheath ' for holding and automatic fixing of the continuous--irrigation inner sheath ' for draining or aspiration of irrigation fluid
C
2.5.3
Resectoscopes with rotatable irrigation ring -- Model Z Continuous--irrigation inner sheath ' for holding and automatic fixing of the working element ' for continuous irrigation fluid supply ' for draining or aspiration of irrigation fluid Z Continuous--irrigation outer sheath ' for holding and automatic fixing of the continuous--irrigation inner sheath
2
GA-D 345
2.6
Resectoscope with intermittent irrigation -- Models
2.6.1
Resectoscopes, rotatable -- Model
D
E
F
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 the working element with endoscope and electrode Z Resectoscope sheath (D1, D2) ' for holding and automatic fixing of the working element ' for 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 reached (stopcock plug in the “0“ position) ' for draining or aspiration of irrigation fluid (stopcock plug in the “OUT” position)
2.6.2
Resectoscope -- 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 ' for 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 reached (stopcock plug in the “0“ position) ' for draining or aspiration of irrigation fluid (stopcock plug in the “OUT” position)
2.6.3
Resectoscopes by Marberger -- Model
F
Z F1 -- resectoscope sheath with rotatable irrigation ring Z F2 -- resectoscope sheath with central stopcock Z Resectoscope sheath (F1) ' for holding and automatic locking of working element ' for continuous irrigation fluid supply Z Resectoscope sheath (F2) ' for continuous irrigation fluid supply (stopcock plug in the “IN” position) ' for maintaining the irrigation fluid once the bladder capacity has been reached (stopcock plug in the “0“ position) ' for draining or aspiration of irrigation fluid (stopcock plug in the “OUT” position)
GA-D 345
3
3
Indications and Field of Use For examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the various medical disciplines, such as Z Urology Z Gynecology For Urology: Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. ' Transurethral resection of the prostate (TURP) ' Transurethral resection of bladder tumors (TURBT) ' Transurethral incision of the prostate and bladder neck ' Coagulation of bleeding in the lower urinary tract For Gynecology: Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. ' Excision of intrauterine myomas ' Excision of intrauterine polyps ' Lysis of intrauterine septa ' Endometrial ablation Long--sheath resectoscopes: e.g. are used in the case of particularly long urethras
4
Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient’s general condition, the physician/surgeon in charge must decide whether the planned use is possible or not. For further information, see the latest medical literature.
5
Combinations Resectoscopes are used in conjunction with: Z Light sources and flexible light cables Z HF surgical devices Z Pumps for irrigation and suction Z Endoscopically controlled accessories: CAUTION! Careful if products are incorrectly combined! Possible injury of the patient, user or others as well as possible damage to the product. 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. Make sure you observe the 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 “E--LINE” resectoscopes with continuous--irrigation double--sheath system / with intermittent irrigation please see Brochure BB--D345.
4
GA-D 345
6
Illustration
6.1
Resectoscope sheaths (continuous--irrigation double--sheath system) -- Models
A
1.3 1.1
1.2
1
2.2
3.5
2.3
2
B
C
3 3.2 * 3.1 3.3 3.4
#
2.1
A
#
9
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 345
5
Legend and Identification
6.1.1
Resectoscope -- Models Item
Designation
A
B
C
rotatable
not rotatable
with rotatable irrigation ring
1
continuous--irrigation inner sheath
J
J
J
1.1
Sheath tube
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 stopcock
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 openings
J
J
J
2.2
Sheath tube
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 adapter
J
j
j
3.1
QUAD lip seal
J
j
j
3.2
Locking collar
J
j
j
3.3
Rotatable adapter
J
j
j
3.4
Locking mechanism
J
J
J
3.5
Tab with color coding
J
J
J
*
Fr.
J
J
J
#
Product no.
J
J
J
J
6
= applicable
j
= not applicable
GA-D 345
D
Resectoscope sheaths (intermittent irrigation) -- Models
6.2
D
1.1
E
F
1.3
1.2
D1
3
#
1.4
3.2 * 3.1 3.3 3.4
9
D2 #
1.5
4.4 4.3
4
3.5
#
D3 4.2
E
1.6
1.11
1.8 1.9
E1
1.10
1
4.1
* 1.7 #
*
6, 7, 8, 10, 11, 12
E2 # E3
5.3 * 5.4
F *
5.2 5.1 5.5
F1
#
5
# F2 # Fig. 2
GA-D 345
7
Legend and Identification
6.2.1
Resectoscope Models Item
D
Designation
E
F
rotatable
by Marberger
D1
D2
D3
E1
E2
E3
F1
F2
1
Resectoscope sheath
J
J
J
J
J
J
J
J
1.1
Sheath tube
J
J
J
J
J
J
J
J
1.2
Thrust washer with color coding
J
J
J
j
j
j
j
j
1.3
Luer connector
J
j
j
J
j
j
J
j
1.4
Irrigation stopcock, disassemblable
j
J
j
j
J
j
j
j
1.5
“IN” connector
j
j
J
j
j
J
j
J
1.6
“OUT” connector
j
j
J
j
j
J
j
J
1.7
Locking mechanism
j
j
j
J
J
j
J
j
1.8
Tab with color coding
j
j
j
J
J
j
J
j
1.9
Threaded ring
j
j
j
J
j
j
J
j
1.10
Irrigation ring with Luer fitting
j
j
j
J
j
j
J
j
1.11
Sealing ring
j
j
j
J
j
j
J
j
2
Not assigned
j
j
j
j
j
j
j
j
3
Rotatable adapter
J
J
J
j
j
j
j
j
3.1
QUAD lip seal
J
J
J
j
j
j
j
j
3.2
Locking collar
J
J
J
j
j
j
j
j
3.3
Rotatable adapter
J
J
J
j
j
j
j
j
3.4
Locking mechanism
J
J
J
j
j
j
j
j
3.5
Tab with color coding
J
J
J
j
j
j
j
j
4
Stopcock plug
j
j
J
j
j
J
j
J
4.1
Stopcock plug
j
j
J
j
j
J
j
J
4.2
Stopcock toggle
j
j
J
j
j
J
j
J
4.3
O--ring (outside)
j
j
J
j
j
J
j
J
4.4
O--ring (face)
j
j
J
j
j
J
j
J
5
Locking body
j
j
j
j
j
J
j
J
5.1
Locking collar
j
j
j
j
j
J
j
J
5.2
Sleeve
j
j
j
j
j
J
j
J
5.3
O--ring
j
j
j
j
j
J
j
J
5.4
Locking mechanism
j
j
j
j
j
J
j
J
5.5
Tab with color coding
j
j
j
j
j
J
j
J
*
Fr.
J
J
J
#
Product no.
J
J
J
D1 = with luer fitting D2 = with irrigation stopcock D3 = with central stopcock E1 = with rotatable irrigation ring E2 = with fixed irrigation stopcock E3 = with central stopcock F1 = with rotatable irrigation ring F2 = with central stopcock
8
GA-D 345
J
6.3
= applicable
j
= not applicable
Obturators, working elements and electrodes
6 7 1
# 8.1 8.2
8 9.1
10
6.1
#
9
¡ ©
9.2 # ¡ ©
Variant ¡
11.1
Variant ©
1 1
11.2 13.1
#
13
# 13.2
#
11.3
¡ ©
12.1
Variant ¡
12
¡ © Variant ©
12.1
Fig. 3
GA-D 345
9
6.3.1
Legend and Identification Item
Designation
Item
Designation
6
Obturator
11
Working element, active Cutting is effected against spring pressure
6.1
Handle with color coding
11.1
Variants: ¡Closed telescope guide tube ©Open telescope guide tube, half--shell--shaped
7
Obturator with moveable head
11.2
Cutting is effected by gear mechnism
8
Viewing obturator
11.3
8.1
Locking lever with color coding
12
Cutting is effected against spring pressure (rotatable)
Working element, passive Cutting is effected by spring pressure
10
8.2
Locking ring
12.1
Variants: ¡ Closed telescope guide tube © Open telescope guide tube, half--shell--shaped
9
Dilation obturator
13
Electrodes
9.1
Flexible obturator shank
13.1
Electrodes for 30 / 25 / 12 working elements
9.2
Moveable handle with color coding
13.2
Electrodes for 5 / 0 working elements
10
Endoscope
14
Not assigned
#
Product no.
GA-D 345
6.4
Electrodes, reprocessable, single--use electrodes, sterile, EVAP electrodes
0 #
G - K
30 / 25 / 12 15 16
17
19
18
#
5 / 0
L - O 30 / 25 / 12
G Pos
0
-
K
L
30 / 25 / 12
G1 G2
-
G3
-
Pos
5 / 0
-
O 30 / 25 / 12
L
M
G4 H1 H2
-
H3
-
N
O
H4
-
H5 I J1 J2
-
K Fig. 4
GA-D 345
11
6.4.1
Legend and Identification Item
Designation
Item
Electrode structure
Designation Electrode structure
15
Electrode head
18
Proximal insulation (stem)
16
Distal insulation (fork)
19
Contact end
17
Guide nose
#
Product no. on electrode (reprocessable) on sterile packaging (single--use)
G -- K
Electrodes, reprocessable Single--use electrodes, sterile
L -- O EVAP electrodes
Electrode shapes
Electrode shapes
G1
Cutting electrode
L
Loop
G2
Cutting electrode for narrow spaces
M
Barrel
G3
Cutting electrode, angle , 45
N
Pyramid
G4
Straight cutting electrode
O
Wing electrode
H1
Large--surface coagulation electrode
H2
Spherical electrode, barrel--shaped
H3
Roller electrode, barrel--shaped
H4
Coagulation electrode
H5
Spherical coagulation electrode
I
Hook electrode
J1
Blade electrode by Collins
J2
Blade electrode
K
Dissecting electrode, arrow--shaped tip
Symbols
Meaning CAUTION, observe ACCOMPANYING DOCUMENTS
REF
Order number Lot no.
SN
Serial number Manufacturing date Units, pieces Use--by date: Do not reuse (for single use only) Sterilized with ethylene oxide Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code number of the notified body (0124).
12
GA-D 345
7
Use WARNING! Do not re- use disposable items! Products marked ”disposable”, i.e. for single use only, have been designed for only one use on or in a single patient. If disposable items are reprocessed to be used again, product quality may deteriorate, which will endanger the patient, user and others. In this case the manufacturer can no longer guarantee the product’s safety and performance. 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
Preparation The following preparatory measures are required for the resectoscopes concerned: Z Check assembly: section 9.7 Z Carry out a check: sections 8 and 8.1
7.1.1
Resectoscope -- Models
A
D
Resectoscope, rotatable (A) (D1) (D2) (D3)
x
Fig. 5
3.1
1
3.3
Z Unscrew the rotatable adapter (3.3) and check that it contains a QUAD lip seal (3.1). Z Check the QUAD lip seal (3.1) for correct position. ' The sealing lip (x) must face the resectoscope sheath (1). Z Firmly tighten the rotatable adapter (3.3).
Fig. 5
GA-D 345
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 continuous--irrigation inner sheath (1) in 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 indicated by the arrow and remove continuous--irrigation inner sheath (1). 2.3
1.2
2
2.5 2.4
1
Fig. 6
7.1.3
Inserting obturator (6) in resectoscope sheath -- Models
A --
F
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 tab (3.5) as far as it will go, then repeat the procedure. Unlocking: Z Push tab (3.5) and remove obturator (6).
a b 3.5
Fig. 7
14
1
3.4
6
GA-D 345
7.1.4
Inserting dilation obturator (9) 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 moveable handle (9.2) up to the stop position (90 position). ' The handle (9.2) is locked in the down position.
.
IMPORTANT! Only when the moveable handle is in the down position, is the flexible obturator shank conically dilated creating an atraumatic transition between the obturator tip and the end of the sheath.
Z Check dilation of flexible obturator shank (9.1). Z Do not use the dilation obturator (9) ' if it is not possible to move the moveable handle (9.2) to its down position. ' if the flexible obturator is damaged (e.g. cracked).
9
9.1
9.2
Fig. 9
GA-D 345
15
7.1.5
Inserting endoscope (10) in viewing obturator (8) -- Models
A --
F
Fig. 10 L The locking lever (8.1) is in position “I”. Locking: Z Insert endoscope (10) in viewing obturator (8). ' The pin (c) engages in the groove (d). Z Turn the locking lever (8.1) to position “II” . ' Both components should be locked together. L Locking lever (8.1) is 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
II c d
I
8
Fig. 10
7.1.6
Inserting electrode (13) in working element (11) (12) -- Models
II
10
A -- F
Fig. 11 Variants -- working element (11) (12) ¡ Closed telescope guide tube © Open telescope guide tube, half--shell--shaped Locking: Z Press and keep depressed the button (W). Z Hold electrode (13) aligned with the cross--sectional shape of the guide tube and insert into the guide tube (X) as far as it will go, then let go of button (W) Z Pull slightly to check that the electrode (13) is securely locked in place. Unlocking: Z Push button (W) and withdraw electrode (13).
¡
©
X
13 W
11 (12)
Fig. 11
16
GA-D 345