Richard Wolf
Cysto-Urethroscopes Instructions for use
54 Pages
Preview
Page 1
Instructions for use
Cysto-urethroscopes Urethro-cystoscopes 8650.xxx/8652.xxx
GA-D321 / en / EU / V1.0 / 2020-12 /
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, 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.
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
2
GA-D321-en-EU V1.0
Contents 1
General safety instructions and guidance for use ...
5
2
General information ...
6
2.1
Safety instructions and levels of danger...
6
2.2
Symbols...
7
3
Product description...
8
4
Intended use... 10
5
Indications ... 12
6
Contraindications and side effects ... 12
6.1
Contraindications... 12
6.2
Side effects... 12
7
Combinations ... 13
7.1
Overview of permissible combinations and requirements ... 13
8
Illustration ... 14
8.1
Endoscope, sheath and obturator for cystoscope ... 14
8.2
Insert and adapter for cystoscope ... 15
9
Checks... 16
9.1
Visual checks ... 16
9.2 9.2.1
Function check ... 17 Stopcock plug ... 17
9.3
Service life ... 18
10
Use ... 19
10.1 10.1.1 10.1.2 10.1.3 10.1.4 10.1.5
Preparation ... 19 Inserting the obturator / viewing obturator into the sheath ... 19 Inserting the endoscope in the viewing obturator ... 21 Inserting the endoscope in the insert / adapter ... 21 Inserting the adapter or insert into the sheath ... 22 Connecting system components ... 23
10.2 10.2.1 10.2.2 10.2.3 10.2.4
General notes and instructions for use... 24 Power ... 24 Laser application ... 24 HF application ... 25 Inserting auxiliary instruments ... 26
11
Reprocessing and maintenance ... 27
11.1 11.1.1 11.1.2 11.1.3 11.1.4 11.1.5 11.1.6 11.1.7
Reprocessing sequence – Sheath for cystoscope ... 30 Machine reprocessing ... 32 Manual reprocessing ... 33 Checks and maintenance ... 34 Packaging... 34 Sterilization ... 34 Storage ... 34 Validation... 35
11.2 11.2.1 11.2.2 11.2.3
Reprocessing sequence – Adapter for cystoscope ... 36 Machine reprocessing ... 36 Manual reprocessing ... 37 Checks and maintenance ... 38
GA-D321-en-EU V1.0
3
11.2.4 11.2.5 11.2.6 11.2.7
Packaging... 39 Sterilization ... 39 Storage ... 39 Validation... 39
11.3 11.3.1 11.3.2 11.3.3 11.3.4 11.3.5 11.3.6 11.3.7 11.3.8
Reprocessing sequence – Insert for cystoscope ... 40 Machine reprocessing ... 41 Manual reprocessing ... 42 Ultrasound ... 43 Checks and maintenance ... 43 Packaging... 44 Sterilization ... 44 Storage ... 44 Validation... 44
11.4 11.4.1 11.4.2 11.4.3 11.4.4 11.4.5 11.4.6 11.4.7
Reprocessing sequence – Obturator for cystoscope... 45 Machine reprocessing ... 45 Manual reprocessing ... 46 Checks and maintenance ... 47 Packaging... 47 Sterilization ... 47 Storage ... 47 Validation... 47
11.5 11.5.1 11.5.2 11.5.3 11.5.4 11.5.5 11.5.6 11.5.7
Reprocessing sequence – Viewing obturator for cystoscope ... 48 Machine reprocessing ... 48 Manual reprocessing ... 49 Checks and maintenance ... 50 Packaging... 50 Sterilization ... 50 Storage ... 50 Validation... 51
12
Technical description... 52
12.1
Operating, storage, transport and shipping conditions ... 52
13
Spare parts ... 53
14
Disposal of product, packaging material and accessories ... 54
4
GA-D321-en-EU V1.0
1
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.
GA-D321-en-EU V1.0
5
2
General information
2.1
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.
6
GA-D321-en-EU V1.0
2.2
Symbols
Symbols
Designation Follow the manual Medical product Product number Lot code Manufacturer Manufacturing date Number, amount
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.
GA-D321-en-EU V1.0
7
3
Product description This instruction manual describes the cysto-urethroscope for Ø 4 mm telescopes with corresponding additional instruments and accessories. The cysto-urethroscope is suitable for placing or removing guide wires and catheters, as well as performing biopsies and foreign body removals. Different adapters and working inserts are available for this purpose.
SHEATH FOR CYSTOSCOPE 8650.0145
SHEATH FOR CYSTOSCOPE 16 Fr.
Color code yellow, SL 231 mm, oval, distal end slanted, capacity for instruments up to 5 Fr., compatible with adapters 8650254, 8650264, 8650.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable
8650.0245
SHEATH FOR CYSTOSCOPE 17.5 Fr.
Color code green, SL 231 mm, oval, distal end slanted, capacity for instruments up to 5 Fr. or 2x4 Fr., compatible with adapters 8650254, 8650264, 8650.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable
8650.0345
SHEATH FOR CYSTOSCOPE 19.5 Fr.
Color code red, SL 231 mm, oval, distal end slanted, capacity for instruments up to 7 Fr. or 2x5 Fr., compatible with adapters 8650254, 8650264, 8650.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable
8650.0445
SHEATH FOR CYSTOSCOPE 21 Fr.
Color code blue, SL 231 mm, oval, distal end slanted, capacity for instruments up to 10 Fr. or 2x6 Fr., compatible with adapters 8650254, 8650264, 8650.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable.
8650.0545
SHEATH FOR CYSTOSCOPE 23 Fr.
Color code white, SL 231 mm, oval, distal end slanted, capacity for instruments up to 12 Fr. or 2x7 Fr., compatible with adapters 8650254, 8650264, 8650.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable
8650.0645
SHEATH FOR CYSTOSCOPE 25 Fr.
Color code black, SL 231 mm, oval, distal end slanted, capacity for instruments up to 15 Fr., compatible with adapters 8650254, 8650264, 8650.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable
8652.0445
SHEATH FOR CYSTOSCOPE 21 Fr.
Color code blue, SL 209 mm, oval, distal end slanted, capacity for instruments up to 10 Fr. or 2x6 Fr., compatible with adapters 8652254, 8652264, 8652.284, and telescopes Ø 4 mm, with 2 irrigation valves, quick-release mechanism, reusable.
ADAPTER FOR CYSTOSCOPE 8652.264
ADAPTER FOR CYSTOSCOPE
TL 79 mm, compatible with sheaths 86520145, 86520245, 86520345, 86520445, and telescopes Ø 4 mm, 0°/12°/30°/70°, with instrument port, bayonet lock, reusable
8650.254
ADAPTER FOR CYSTOSCOPE
only for diagnostics, TL 60 mm, compatible with sheaths 86500145, 86500245, 86500345, 86500445, 86500545, 86500645, and telescopes Ø 4 mm, 0°/12°/30°/70°, without instrument port, bayonet lock, reusable
8650.264
ADAPTER FOR CYSTOSCOPE
TL 60 mm, compatible with sheaths 86500145, 86500245, 86500345, 86500445, 86500545, 86500645, and telescopes Ø 4 mm, 0°/12°/30°/70°, with instrument port, bayonet lock, reusable
8
GA-D321-en-EU V1.0
8650.284
ADAPTER FOR CYSTOSCOPE
TL 60 mm, compatible with sheaths 86500145, 86500245, 86500345, 86500445, 86500545, 86500645, and telescopes Ø 4 mm, 0°/12°/30°/70°, with 2 instrument ports, bayonet lock, reusable
OBTURATOR FOR CYSTOSCOPE 8650.0147
OBTURATOR FOR CYSTO- Color code yellow, WL 249 mm, oval, distal end rounded, compatible SCOPE 16 Fr. with sheath 86500145, reusable
8650.0247
OBTURATOR FOR CYSTO- Color code green, WL 249 mm, oval, distal end rounded, compatible SCOPE 17.5 Fr. with sheath 86500245, reusable
8650.0347
OBTURATOR FOR CYSTO- Color code red, SL 251 mm, oval, distal end rounded, compatible with SCOPE 19.5 Fr. sheath 86500345, reusable
8650.0447
OBTURATOR FOR CYSTO- Color code blue, WL 249 mm, oval, distal end rounded, compatible SCOPE 21 Fr. with sheath 86500445, reusable
8650.0547
OBTURATOR FOR CYSTO- Color code white, WL 249 mm, oval, distal end rounded, compatible SCOPE 23 Fr. with sheath 86500545, reusable
8650.0647
OBTURATOR FOR CYSTO- Color code black, WL 249 mm, oval, distal end rounded, compatible SCOPE 25 Fr. with sheath 86500645, reusable
8652.0447
OBTURATOR FOR CYSTO- TL 60 mm, compatible with sheaths 86500145, 86500245, 86500345, SCOPE 21 Fr. 86500445, 86500545, 86500645, and telescopes 4 mm, 0°/12°/30°/70°, with 2 instrument ports, bayonet lock, reusable
VIEWING OBTURATOR FOR CYSTOSCOPE 8650.714
VIEWING OBTURATOR FOR WL 249 mm, distal end rounded, compatible with sheath 86500245, CYSTOSCOPE 17.5 Fr. and telescopes Ø 4 mm, 0°/12°/30°, bayonet lock, reusable
8650.724
VIEWING OBTURATOR FOR WL 249 mm, distal end rounded, compatible with sheath 86500345, CYSTOSCOPE 19.5 Fr. and telescopes Ø 4 mm, 0°/12°/30°, bayonet lock, reusable
8650.734
VIEWING OBTURATOR FOR WL 249 mm, distal end rounded, compatible with sheath 86500445, CYSTOSCOPE 21 Fr. and telescopes Ø 4 mm, 0°/12°/30°, bayonet lock, reusable
8650.744
VIEWING OBTURATOR FOR WL 249 mm, distal end rounded, compatible with sheath 86500545, CYSTOSCOPE 23 Fr. and telescopes Ø 4 mm, 0°/12°/30°, bayonet lock, reusable
WORKING INSERT FOR CYSTOSCOPE 8650.204
WORKING INSERT FOR CYSTOSCOPE 0/30/70
with Albarran deflector, compatible with sheaths 86500245, 86500345, 86500445, 86500545, and telescopes Ø 4 mm, with 2 instrument ports, bayonet lock, reusable
8650.214
WORKING INSERT FOR CYSTOSCOPE 30/70
with Albarran deflector, compatible with sheaths 86500245, 86500345, 86500445, 86500545, and telescopes Ø 4 mm, with instrument port, bayonet lock, reusable
GA-D321-en-EU V1.0
9
4
Intended use Cystoscope sheaths 8650.0145
SHEATH FOR CYSTOSCOPE 16 Fr.
8650.0245
SHEATH FOR CYSTOSCOPE 17.5 Fr.
8650.0345
SHEATH FOR CYSTOSCOPE 19.5 Fr.
8650.0445
SHEATH FOR CYSTOSCOPE 21 Fr.
8650.0545
SHEATH FOR CYSTOSCOPE 23 Fr.
8650.0645
SHEATH FOR CYSTOSCOPE 25 Fr.
8652.0445
SHEATH FOR CYSTOSCOPE 21 Fr.
The products are used for access to the operating field and for the supply and drainage of irrigation fluids Cystoscope adapters 8652.264
ADAPTER FOR CYSTOSCOPE
8650.264 8650.284 The products are used for connecting sheaths to telescopes and for inserting auxiliary instruments. 8650.254
ADAPTER FOR CYSTOSCOPE
The products are used for connecting sheaths to telescopes. Cystoscope obturators 8650.0147
OBTURATOR FOR CYSTOSCOPE 16 Fr.
8650.0247
OBTURATOR FOR CYSTOSCOPE 17.5 Fr.
8650.0347
OBTURATOR FOR CYSTOSCOPE 19.5 Fr.
8650.0447
OBTURATOR FOR CYSTOSCOPE 21 Fr.
8650.0547
OBTURATOR FOR CYSTOSCOPE 23 Fr.
8650.0647
OBTURATOR FOR CYSTOSCOPE 25 Fr.
8652.0447
OBTURATOR FOR CYSTOSCOPE 21 Fr.
The products are used for atraumatic insertion of cystoscope sheaths, which are used in combination with cystoscope components for endoscopic visualization of the bladder, urethra, and ureter.
10
GA-D321-en-EU V1.0
Cystoscope viewing obturators 8650.714
VIEWING OBTURATOR FOR CYSTOSCOPE 17.5 Fr.
8650.724
VIEWING OBTURATOR FOR CYSTOSCOPE 19.5 Fr.
8650.734
VIEWING OBTURATOR FOR CYSTOSCOPE 21 Fr.
8650.744
VIEWING OBTURATOR FOR CYSTOSCOPE 23 Fr.
The products are used for atraumatic insertion of cystoscope sheaths under visual control, which are used in combination with further cystoscope components for endoscopic visualization of the urinary bladder, urethra, and ureter. Cystoscope working inserts 8650.204
WORKING INSERT FOR CYSTOSCOPE 0/30/70
8650.214
WORKING INSERT FOR CYSTOSCOPE 30/70
The products are used for inserting auxiliary instruments and a telescope into the sheath. User These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
GA-D321-en-EU V1.0
11
5
Indications The products are used in lower urinary tract urology for the following indications: Lithotripsy in the bladder n Foreign body removal in the bladder n Tumor removal in the bladder n Diagnostic cystoscopy n Incontinence therapy n Reflux therapy n Bladder neck incisions n Urethrotomy The same indications apply for accessories of the listed medical devices. n
Patient group The intended patient group is not limited with regard to ethnicity, age, sex, height, or weight. On the basis of the latest medical knowledge and the patient's condition, the doctor in charge must decide whether the planned use is possible or not.
6
Contraindications and side effects
6.1
Contraindications There are currently no known contraindications directly related to the product in hysteroscopy. Medical contraindications in hysteroscopy, e.g., pregnancy, exclude the use of the products concerned. There are currently no known contraindications directly related to the products in urology. Medical contraindications for the aforementioned procedures exclude the use of the products concerned.
6.2
Side effects No side effects directly related to the product are known if the system is used as intended.
12
GA-D321-en-EU V1.0
7
Combinations CAUTION Be careful not to combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n The products must only be used jointly if the intended use and the relevant technical data such as working length, diameter, etc. are the same. n Also follow the instruction manuals of the products used in conjunction with this product.
7.1
Overview of permissible combinations and requirements The products are used with: n n n n n n
GA-D321-en-EU V1.0
Endoscopic cameras and light sources Endoscopic devices Suction and irrigation pumps Endoscopic instruments and accessories HF surgical generators Devices for lithotripsy
13
8
Illustration
8.1
Endoscope, sheath and obturator for cystoscope
1 2.1 8650.
2.1.1 2.1.2
2.5
2.2
2
2.3
2.4.2 8652.
2.4.1
2.4
3
3.1
4.1
4
4.2
Fig. 1 Legend and identification Item
Designation
Item
Designation
1
Endoscope
3
Obturator for cystoscope
2
Sheath for cystoscope
3.1
Color bolt
2.1
Supply stopcock
2.1.1
Stopcock insert
4
Viewing obturator for cystoscope
2.1.2
Stopcock housing
4.1
Clamping handle with color coding
2.2
Locking mechanism
4.2
Locking mechanism
2.3
Tab with color coding
2.4
Drain stopcock
2.4.1
Stopcock insert
2.4.2
Stopcock housing
2.5
DataMatrix code
14
GA-D321-en-EU V1.0
8.2
Insert and adapter for cystoscope 5.3
5A
5.4 5.5
5.2
5.6
5
5.1
5.6.1
5.7
5.6.2
5.8
5B 6A
6 6C
6.1 6.2 6.3
6B 6.3.2
6.4
6.3.1
Fig. 2 Legend and identification Item
Designation
Item
5
Working insert for cystoscope
6
Adapter for cystoscope
5A
With 1 instrument port
6A
With 1 instrument port
5B
With 2 instrument ports
6B
With 2 instrument ports
5.1
Albarran deflector
6C
Only for diagnostics
5.2
Control cables
6.1
Clamping handle
5.3
Drive wheels
6.2
Locking mechanism
5.4
Clamping handle
6.3
Instrument port
5.5
Locking mechanism
6.3.1
Stopcock insert
5.6
Instrument port
6.3.2
Stopcock housing
5.6.1
Stopcock insert
6.4
Rubber cap
5.6.2
Stopcock housing
5.7
Rubber cap
5.8
DataMatrix code
GA-D321-en-EU V1.0
Designation
15
9
Checks WARNING Injury due to damaged or incomplete products! Injuries of the patient, user and others are possible. n Run through the checks before and after each use. n Do not use the products if they are damaged, incomplete or have loose parts. n Do not attempt to do any repairs yourself.
ATTENTION Send in damaged or incomplete products together with any loose parts for repair. Repair only by authorized experts.
9.1
Visual checks 1. Check the products, in particular their distal area, and the accessories for: ð damage ð surface changes (such as corrosion) ð sharp edges ð loose or missing parts ð rough surfaces 2. Any inscriptions or identification necessary for the safe intended use must be legible. ð Missing or illegible inscriptions, labels and identifications that may lead to wrong handling or reprocessing must be reinstated. 3. Check the rubber caps (5.7) and (6.4) for damage ð Replace damaged and brittle rubber caps.
5.7 / 6.4
Fig. 3
16
GA-D321-en-EU V1.0
9.2
Function check 1. Check all components for easy assembly. Replace the products if the connection is not secure or is difficult to assemble or screw together. 2. Check for secure connections. 3. Check for easy insertion of the auxiliary instruments through the instrument port. ð Do not use bent instruments. 4. Check the suction and irrigation function before each use. 5. Check image quality. 6. Check the angular position of the Albarran deflector (5.1). ð The Albarran deflector (5.1) is angled by turning the drive wheels (5.3).
5.1
5.3
Fig. 4
¯ Check the entire system for leak-tightness and free passage (patency).
9.2.1
Stopcock plug 1. Check that the stopcock insert can be felt to engage in the stopcock housing. 2. Check the leak tightness of the stopcock. ð Connect the supply tube, turn the stopcock insert to the locked position. ð If the stopcock is not leak tight: Replace the stopcock insert. 3. Check the easy operation of the stopcock insert in the stopcock housing.
Fig. 5
GA-D321-en-EU V1.0
17
9.3
Service life ATTENTION For the service life of the products, careful and gentle handling during use and during the entire reprocessing process is essential When used as intended and following the instructions in the manufacturer's instructions for use, it is not necessary to limit the service life of the medical products. If one or several criteria of the described checks are not passed, the medical product must be replaced or returned for repair (by the OEM or a repair facility authorized by the OEM) if necessary.
18
GA-D321-en-EU V1.0
10
Use 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.
10.1
Preparation 1. Position the rubber cap (5.7) (6.4). ð The example of the rubber cap (5.7) for the working insert (5) is shown in the diagram. The same applies to the rubber cap (6.4) on the adapter (6).
5.7 Fig. 6 2. Perform a visual check ð see section 9.1 Visual checks
10.1.1
Inserting the obturator / viewing obturator into the sheath CAUTION Tissue damage! Do not insert the sheath without the obturator! This may result in unintentional tissue damage. Only insert the sheath atraumatically with the obturator in place. Insertion into the sheath (2) is illustrated and described using the obturator (3) as an example. The same procedure applies for the viewing obturator. Locking: 1. Insert the obturator (3) into the sheath (2). ð The groove (a) and pin (b) are in one plane. 2. Push the connection together until it automatically locks into place.
GA-D321-en-EU V1.0
19
a
2
b
3
Fig. 7
NOTE If the connection does not lock automatically, press the tab as far as it will go and repeat the process. Releasing: ¯ Press the tab (2.3) and remove the obturator (3).
2.3
3
Fig. 8
20
GA-D321-en-EU V1.0