Richard Wolf
Resectoscopes Instructions for use
83 Pages
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Page 1
Instructions for use
Resectoscopes Continuous irrigation double sheath system (8655.xxx) with intermittent irrigation (8654.xxx / 8661.xxx / 8663.xxx / 8668.xxx)
GA-D345 / en / EU / 2020-12 V1.0 /
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
Subject to technical changes! Due to ongoing development, the product descriptions, figures, and technical data may deviate slightly from the current state. For further information about our products, please contact Richard Wolf GmbH or a local representative.
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 information ...
5
1.1
Safety instructions and levels of danger...
5
1.2
Symbols...
5
2
General safety instructions and guidance for use ...
7
3
Product description...
8
4
Intended use... 16
5
Indications ... 20
6
Contraindications and side effects ... 25
6.1
Contraindications... 25
6.2
Side effects... 25
7
Combinations ... 26
7.1
Overview of permissible combinations and requirements ... 26
8
Illustration ... 27
8.1
Resectoscope sheaths (continuous irrigation double sheath system) – Models [ A ] [ B ] ... 27
8.2
Resectoscope sheaths (intermittent irrigation) – Models [ C ] [ D ] ... 29
8.3
Obturators, working elements, and electrodes ... 32
8.4
Multiple use electrodes, reprocessable, disposable electrodes, sterile, EVAP electrodes ... 34
9
Checks... 36
9.1 9.1.1 9.1.2 9.1.3 9.1.4
Visual checks ... 36 HF monopolar connection cable... 36 Resectoscope sheaths ... 37 Resectoscope – Models [ A ] – [ D ] ... 37 Electrodes ... 38
9.2 9.2.1 9.2.2
Function check ... 39 Resectoscope – Models [ A ] – [ D ] ... 39 Removable irrigation valve and outlet tap ... 39
9.3
Service life ... 40
10
Use ... 41
10.1 10.1.1 10.1.2 10.1.3 10.1.4 10.1.5 10.1.6 10.1.7 10.1.8 10.1.9 10.1.10
Preparation / Commissioning ... 42 Resectoscope – Models [ A ] [ C ] ... 42 Inserting the continuous irrigation inner sheath into the continuous irrigation outer sheath – Models [ A ] [ B ] ... 42 Resectoscope sheaths (intermittent irrigation) – Models [ C ] [ D ] ... 43 Inserting the obturator into the resectoscope sheath – Models [ A ] – [ D ] ... 44 Inserting the dilatations obturator into the resectoscope sheath – Models [ A ] [ C ]... 44 Inserting the telescope into the viewing obturator – Models [ A ] – [ D ] ... 46 Inserting the viewing obturator with telescope into the resectoscope sheath – Models [ A ] – [ D ] ... 46 Inserting the electrode into the working element – Models [ A ] – [ D ]... 47 Inserting the endoscope into the working element – Models [ A ] – [ D ] ... 47 Inserting the working element into the resectoscope sheath – Models [ A ] – [ D ] ... 48
10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5
General notes and instructions for use... 48 Connecting the resectoscope sheath to the irrigation and suction system ... 48 Resectoscope – Models [ A ] – [ D ] ... 49 Connecting the resectoscope to system components ... 50 Irrigation / suction ... 51 HF application ... 51
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11
Reprocessing and maintenance ... 55
11.1
Reprocessing sequence – Electrodes ... 59
11.2
Reprocessing sequence – Sheath... 63
11.3
Reprocessing sequence – Working element ... 72
11.4
Reprocessing sequence – Obturator ... 77
12
Technical description... 81
12.1
Use, storage, transport, and shipping conditions ... 81
13
Spare parts ... 82
14
Disposal of product, packaging material and accessories ... 83
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GA-D345
1
General information
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.
1.2
Symbols
Symbols
Designation Follow the instruction manual Follow the manual Medical device Product number Serial Number Lot code Manufacturer Manufacturing date Do not reuse! Do not resterilize
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Symbols
Designation Number, amount
Expiry date Sterilized with ethylene oxide Do not use if package is damaged Keep away from sunlight!
Store in a dry place!
Temperature, limitation
Humidity, limitation
Data Matrix Code
CE identification with code number of the competent authority in conformity with Directive 93/42/ EEC on medical products or EU regulation 2017/745 on medical products. Only valid if the product and/or the packaging is marked with this identification. Products where a notified body is not involved in the conformity assessment procedure are marked with the CE-identification without the code number of the notified body. 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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General safety instructions and guidance 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 products 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. Any severe incident occurring in conjunction with this product must be reported to the manufacturer and the competent authority of the country where the user and/ or patient resides.
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Product description This instruction manual describes resectoscopes with corresponding additional instruments and accessories. The instrument set has different sheath diameters of 24 Fr. and 26 Fr. The products are intended for intermittent irrigation or continuous irrigation. In addition, different working elements are available. Likewise, electrodes with different designs can be applied. EVAP, hook, COAG, knife, and cutting electrodes can be used.
Fig. 1 OUTER SHEATH FOR RESECTOSCOPE 8655.334 OUTER SHEATH FOR RESECTOSCOPE 24.5 FR. Color code green, SL 191 mm, round, not rotatable, distal end straight, continuous irrigation, compatible with inner sheath 8655344, and telescopes Ø 4 mm, 30°, with irrigation valve, E-Line quick-release mechanism, reusable 8655.374 OUTER SHEATH FOR RESECTOSCOPE 26 FR. Color code yellow, SL 191 mm, round, not rotatable, distal end straight, continuous irrigation, compatible with inner sheath 8655384, and telescopes Ø 4 mm, 0°, with irrigation valve, E-Line quick-release mechanism, reusable INNER SHEATH FOR RESECTOSCOPE
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8655.3441 INNER SHEATH FOR RESECTOSCOPE 24.5 FR. Color code green, SL 203 mm, round, not rotatable, distal end straight, continuous irrigation, compatible with outer sheath 8655334, and telescopes Ø 4 mm, 0°/12°/30°, with irrigation valve, reusable
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8655.3841 INNER SHEATH FOR RESECTOSCOPE 26 FR. Color code yellow, SL 204 mm, round, not rotatable, distal end straight, continuous irrigation, compatible with outer sheath 8655374, and telescopes Ø 4 mm, 0°/12°/30°, with irrigation valve, reusable
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EVAP ELECTRODE MONO 8423.031 EVAP ELECTRODE MONO 22–26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27/28/28.9 Fr., electrode shape: barrel, branch color green, stem color blue, PU = 1 PC, for ELine resectoscopes, unsterile, reusable 8422.151 EVAP ELECTRODE MONO 22 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24.5/25.5 Fr., wing (flat bracket profile), branch color blue, stem color blue, PU = 1 PC, for ELine resectoscopes, unsterile, reusable 8423.131 EVAP ELECTRODE MONO 24–26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27/28 Fr., electrode shape: pyramid, branch color green, stem color red, PU = 1 PC, for ELine resectoscopes, unsterile, reusable 8424.081 EVAP ELECTRODE MONO 24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.8 mm, branch color green, stem color blue, PU = 1 PC, for ELine resectoscopes, unsterile, reusable HOOK ELECTRODE MONO 8423.09 HOOK ELECTRODE MONO 22–24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27 Fr., electrode shape: hook, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 48423.095 HOOK ELECTRODE MONO 22–25 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5 Fr., electrode shape: hook, branch color transparent, stem color red, PU = 5 PCS, for E-Line resectoscopes, sterile, disposable
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8420.09 HOOK ELECTRODE MONO 22–26 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/25.5/26/28 Fr., electrode shape: hook, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8427.092 HOOK ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., electrode shape: hook, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable COAG ELECTRODE MONO 8410.02 COAG ELECTRODE MONO 22–24 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/25.5/26/27 Fr., electrode shape: roller, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8423.02 COAG ELECTRODE MONO 22–24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27 Fr., electrode shape: roller, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8423.01 COAG ELECTRODE MONO 22–24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/25.5/26/27 Fr., electrode shape: button, branch color blue, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 48423.025 COAG ELECTRODE MONO 22–25 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27 Fr., electrode shape: roller, branch color transparent, stem color red, PU = 5 PCS, for E-Line resectoscopes, sterile, disposable 8422.435 COAG ELECTRODE MONO 22–26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27/28/28.9 Fr., electrode shape: barrel, branch color green, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable
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8423.023 COAG ELECTRODE MONO 22–26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27/28/28.9 Fr., electrode shape: roller, branch color brown, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8440.02 COAG ELECTRODE MONO 24 FR. 25° For long sheath resectoscopes, for sheaths, intermittent irrigation, 24 Fr., electrode shape: roller, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8427.02 COAG ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., electrode shape: roller, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8427.022 COAG ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., electrode shape: roller, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable LONG SHEATH FOR RESECTOSCOPE -
8668.024 LONG SHEATH FOR RESECTOSCOPE 24 FR. Color code yellow, SL 257 mm, round, rotatable irrigation ring, distal end oblique, ceramic, intermittent irrigation, compatible with telescopes Ø 4 mm, 25° instrument port, reusable
KNIFE ELECTRODE MONO 8423.19 KNIFE ELECTRODE MONO 22–24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27 Fr., electrode shape: knife, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8427.19 KNIFE ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., electrode shape: knife, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable
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8427.192 KNIFE ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., electrode shape: knife, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable SHEATH FOR RESECTOSCOPE -
8663.3741 SHEATH FOR RESECTOSCOPE 24 FR. Color code yellow, SL 195 mm, round, distal end straight, ceramic, intermittent irrigation, for E-Line sheath 8663374, with irrigation valve, reusable
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8663.3841 SHEATH FOR RESECTOSCOPE 26 FR. Color code black, SL 195 mm, round, distal end straight, ceramic, intermittent irrigation, for E-Line sheath 8663384, with irrigation valve, reusable
CUTTING ELECTRODE MONO 8423.04 CUTTING ELECTRODE MONO 22–24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27 Fr., loop: straight, branch color blue, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8422.335 CUTTING ELECTRODE MONO 22–26 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24.5/25.5 Fr., loop: round, wire Ø 0.35 mm, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8422.235 CUTTING ELECTRODE MONO 22–26 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27/28 Fr., loop: round, wire Ø 0.35 mm, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8409.351 CUTTING ELECTRODE MONO 22 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/28 Fr., loop: round, wire Ø 0.35 mm, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable
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8422.131 CUTTING ELECTRODE MONO 22 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24.5/25.5 Fr., loop: round, wire Ø 0.3mm, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8422.351 CUTTING ELECTRODE MONO 22 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 22/24/24.5/25.5/26/27/28 Fr., loop: round, wire Ø 0.35 mm, branch color blue, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 48424.1310 CUTTING ELECTRODE MONO 24–27 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.3 mm, branch color transparent, stem color red, PU = 10 PCS, for E-Line resectoscopes, sterile, for single use 48424.1410 CUTTING ELECTRODE MONO 24–27 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.4 mm, branch color transparent, stem color blue, PU = 10 PCS, for E-Line resectoscopes, sterile, for single use 8411.03 CUTTING ELECTRODE MONO 24 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.3 mm, branch color green, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8411.04 CUTTING ELECTRODE MONO 24 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.4 mm, branch color green, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8424.131 CUTTING ELECTRODE MONO 24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.3 mm, branch color green, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable
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8424.141 CUTTING ELECTRODE MONO 24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., loop: round, wire Ø 0.4 mm, branch color green, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8424.351 CUTTING ELECTRODE MONO 24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, continuous irrigation, 27 Fr., loop: round, wire Ø 0.35 mm, branch color brown, stem color red, PU = 1 PC, for Marberger type resectoscopes, unsterile, reusable 8439.03 CUTTING ELECTRODE MONO 24 FR. 25° For long sheath resectoscopes, for sheaths, intermittent irrigation, 24 Fr., loop: round, wire Ø 0.3 mm, branch color green, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8412.042 CUTTING ELECTRODE MONO 26 FR. 0° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., loop: round, wire Ø 0.4 mm, branch color white, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8426.131 CUTTING ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., loop: round, wire Ø 0.3 mm, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8426.132 CUTTING ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., loop: round, wire Ø 0.3 mm, branch color white, stem color red, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8426.141 CUTTING ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., loop: round, wire Ø 0.4 mm, branch color white, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8426.142 CUTTING ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., loop: round, wire Ø 0.4 mm, branch color white, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable
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8428.142 CUTTING ELECTRODE MONO 28 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation, 28 Fr., loop: round, wire Ø 0.4 mm, branch color yellow, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable WING ELECTRODE MONO 8424.151 WING ELECTRODE MONO 24 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 24/26/27 Fr., wing (flat bracket profile), branch color green, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable 8426.151 WING ELECTRODE MONO 26 FR. 12/30° For resectoscopes, telescope Ø 4 mm, for sheaths, intermittent irrigation / continuous irrigation, 26/28 Fr., wing (flat bracket profile), branch color white, stem color blue, PU = 1 PC, for E-Line resectoscopes, unsterile, reusable
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Intended use Resectoscope – multiple use electrodes
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8423.031
EVAP ELECTRODE MONO 22–26 FR. 12/30°
8422.151
EVAP ELECTRODE MONO 22 FR. 12/30°
8423.131
EVAP ELECTRODE MONO 24–26 FR. 12/30°
8424.081
EVAP ELECTRODE MONO 24 FR. 12/30°
8423.09
HOOK ELECTRODE MONO 22–24 FR. 12/30°
8420.09
HOOK ELECTRODE MONO 22–26 FR. 0°
8427.092
HOOK ELECTRODE MONO 26 FR. 12/30°
8410.02
COAG ELECTRODE MONO 22–24 FR. 0°
8423.02
COAG ELECTRODE MONO 22–24 FR. 12/30°
8423.01
COAG ELECTRODE MONO 22–24 FR. 12/30°
8422.435
COAG ELECTRODE MONO 22–26 FR. 12/30°
8423.023
COAG ELECTRODE MONO 22–26 FR. 12/30°
8440.02
COAG ELECTRODE MONO 24 FR. 25°
8427.02
COAG ELECTRODE MONO 26 FR. 12/30°
8427.022
COAG ELECTRODE MONO 26 FR. 12/30°
8423.19
KNIFE ELECTRODE MONO 22–24 FR. 12/30°
8427.19
KNIFE ELECTRODE MONO 26 FR. 12/30°
8427.192
KNIFE ELECTRODE MONO 26 FR. 12/30°
8423.04
CUTTING ELECTRODE MONO 22–24 FR. 12/30°
8422.335
CUTTING ELECTRODE MONO 22–26 FR. 0°
8422.235
CUTTING ELECTRODE MONO 22–26 FR. 0°
8409.351
CUTTING ELECTRODE MONO 22 FR. 0°
8422.131
CUTTING ELECTRODE MONO 22 FR. 12/30°
8422.351
CUTTING ELECTRODE MONO 22 FR. 12/30°
8411.03
CUTTING ELECTRODE MONO 24 FR. 0°
8411.04
CUTTING ELECTRODE MONO 24 FR. 0°
8424.131
CUTTING ELECTRODE MONO 24 FR. 12/30°
8424.141
CUTTING ELECTRODE MONO 24 FR. 12/30°
8424.351
CUTTING ELECTRODE MONO 24 FR. 12/30°
8439.03
CUTTING ELECTRODE MONO 24 FR. 25°
8412.042
CUTTING ELECTRODE MONO 26 FR. 0°
8426.131
CUTTING ELECTRODE MONO 26 FR. 12/30°
8426.132
CUTTING ELECTRODE MONO 26 FR. 12/30°
8426.141
CUTTING ELECTRODE MONO 26 FR. 12/30°
GA-D345
8426.142
CUTTING ELECTRODE MONO 26 FR. 12/30°
8428.142
CUTTING ELECTRODE MONO 28 FR. 12/30°
8424.151
WING ELECTRODE MONO 24 FR. 12/30°
8426.151
WING ELECTRODE MONO 26 FR. 12/30°
The products are used combined with a HF device for ablating, severing, cutting, coagulating, and vaporizing soft tissue. Resectoscope – disposable electrodes 48423.095
HOOK ELECTRODE MONO 22–25 FR. 12/30°
48423.025
COAG ELECTRODE MONO 22–25 FR. 12/30°
48424.1310
CUTTING ELECTRODE MONO 24–27 FR. 12/30°
48424.1410
CUTTING ELECTRODE MONO 24–27 FR. 12/30°
The products are used combined with a HF device for ablating, severing, cutting, coagulating, and vaporizing soft tissue. Resectoscope sheaths – irrigation and drain connection 8663.3741
SHEATH FOR RESECTOSCOPE 24 FR.
8663.3841
SHEATH FOR RESECTOSCOPE 26 FR.
The products are used for introducing irrigation fluid, and for suction of fluids and tissue. Resectoscope sheaths – with irrigation connection 8655.3441
INNER SHEATH FOR RESECTOSCOPE 24.5 FR.
8655.3841
INNER SHEATH FOR RESECTOSCOPE 26 FR.
8668.024
LONG SHEATH FOR RESECTOSCOPE 24 FR.
The products are used for access to the operating field and the supply of irrigation fluid. Resectoscope sheaths – with drain connection 8655.334
OUTER SHEATH FOR RESECTOSCOPE 24.5 FR.
8655.374
OUTER SHEATH FOR RESECTOSCOPE 26 FR.
The products are used for access to the operating field, and for suction of fluids and tissue. Resectoscope working elements
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8654.204
WORKING ELEMENT, ACTIVE, MONO 12/30°
8654.205
WORKING ELEMENT, ACTIVE, MONO 12/30°
8668.204
WORKING ELEMENT, ACTIVE, MONO 25°
8654.224
WORKING ELEMENT, PASSIVE, MONO 12/30°
8654.2245
WORKING ELEMENT, PASSIVE, MONO 12/30°
8654.225
WORKING ELEMENT, PASSIVE, MONO 12/30°
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8654.2255
WORKING ELEMENT, PASSIVE, MONO 12/30°
8668.225
WORKING ELEMENT, PASSIVE, MONO 25°
The products are used for removing and fixing telescopes, and for controlled insertion of electrodes into the operating field. Resectoscope obturators 8654.17
OBTURATOR FOR RESECTOSCOPE 24 FR.
8654.18
OBTURATOR FOR RESECTOSCOPE 26 FR.
8654.16
OBTURATOR FOR RESECTOSCOPE 22 FR.
8654.12
OBTURATOR FOR RESECTOSCOPE 24 FR.
8654.67
OBTURATOR FOR RESECTOSCOPE 24 FR.
8654.68
OBTURATOR FOR RESECTOSCOPE 26 FR.
8668.12
OBTURATOR FOR RESECTOSCOPE 24 FR.
The products are used for atraumatic insertion of resectoscope sheaths, which are used in combination with additional resectoscope components for endoscopically controlled tissue ablation. Resectoscope viewing obturators 8415.12
VIEWING OBTURATOR FOR RESECTOSCOPE 24 FR.
8415.13
VIEWING OBTURATOR FOR RESECTOSCOPE 26 FR.
8415.11
VIEWING OBTURATOR FOR RESECTOSCOPE 22 FR.
8415.02
VIEWING OBTURATOR FOR RESECTOSCOPE 24 FR.
8415.03
VIEWING OBTURATOR FOR RESECTOSCOPE 26 FR.
The products are used for atraumatic introduction of resectoscope sheaths with visual checks. In combination with resectoscope components, the products are used for endoscopically controlled tissue ablation. Resectoscope dilatations obturators 8654.175
DILATATIONS OBTURATOR FOR RESECTOSCOPE 24 FR.
The products are used for atraumatic introduction of resectoscope sheaths with visual checks. In combination with resectoscope components, the products are used for endoscopically controlled tissue ablation. Resectoscope connection parts 8654.3742
CONNECTION PART FOR RESECTOSCOPE 24 FR.
8654.3842
CONNECTION PART FOR RESECTOSCOPE 26 FR.
8654.3642
CONNECTION PART FOR RESECTOSCOPE 22.5 FR.
The products are used to connect the inner sheath of the resectoscope to the working element, and thus facilitate the insertion of auxiliary instruments.
18
GA-D345
Interdisciplinary stopcocks and tube with LUER-LOCK connector 884.00
STOPCOCK LUER-LOCK CONNECTION Ø 3 MM
884.01
STOPCOCK LUER-LOCK CONNECTION Ø 4 MM
The products are used to connect endoscopes to suction irrigation pumps, and thus enable the introduction of irrigation fluid, as well as the drainage of fluids, secretions, or smoke during endoscopic interventions.
User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.
GA-D345
19
5
Indications The products are used in hysteroscopy for the following indications: ⊳ Myoma resection (a) ⊳ Polyp resection (b) ⊳ Endometrial ablation (c) ⊳ Diagnostic hysteroscopy (d)
For the individual products, the indications are broken down in the following table. The same indications apply for accessories of the listed medical devices.
Medical device
Indication (a)
(b)
(c)
(d)
8663.3741
SHEATH FOR RESECTOSCOPE 24 FR.
x
8663.3841
SHEATH FOR RESECTOSCOPE 26 FR.
x
8668.024
LONG SHEATH FOR RESECTOSCOPE 24 FR.
x
8655.334
OUTER SHEATH FOR RESECTOSCOPE 24.5 FR.
x
x
x
x
8655.374
OUTER SHEATH FOR RESECTOSCOPE 26 FR.
x
x
x
x
8655.3441
INNER SHEATH FOR RESECTOSCOPE 24.5 FR.
x
x
x
x
8655.3841
INNER SHEATH FOR RESECTOSCOPE 26 FR.
x
x
x
x
8423.031
EVAP ELECTRODE MONO 22–26 FR. 12/30°
x
x
8422.151
EVAP ELECTRODE MONO 22 FR. 12/30°
8423.131
EVAP ELECTRODE MONO 24–26 FR. 12/30°
x
x
8424.081
EVAP ELECTRODE MONO 24 FR. 12/30°
x
x
8423.09
HOOK ELECTRODE MONO 22–24 FR. 12/30°
x
x
48423.095
HOOK ELECTRODE MONO 22–25 FR. 12/30°
x
x
8420.09
HOOK ELECTRODE MONO 22–26 FR. 0°
x
x
8427.092
HOOK ELECTRODE MONO 26 FR. 12/30°
x
x
8410.02
COAG ELECTRODE MONO 22–24 FR. 0°
x
x
8423.01
COAG ELECTRODE MONO 22–24 FR. 12/30°
x
x
x
8423.02
COAG ELECTRODE MONO 22–24 FR. 12/30°
x
x
x
48423.025
COAG ELECTRODE MONO 22–25 FR. 12/30°
x
x
x
8422.435
COAG ELECTRODE MONO 22–26 FR. 12/30°
x
x
x
8423.023
COAG ELECTRODE MONO 22–26 FR. 12/30°
x
x
x
8440.02
COAG ELECTRODE MONO 24 FR. 25°
x
x
x
8427.02
COAG ELECTRODE MONO 26 FR. 12/30°
x
x
x
20
x
GA-D345