Cysto-Urethroscope Small-Caliber Instructions for Use

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

Copyright © RICHARD WOLF GmbH

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

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Contents 1

General information ...

4

1.1

Safety instructions and levels of danger...

4

1.2

Symbols...

5

2

General safety instructions and guidance for use ...

6

3

Product description...

7

4

Intended use...

8

5

Indications ...

9

6

Contraindications and side effects ...

9

6.1

Contraindications...

9

6.2

Side effects...

9

7

Combinations ... 10

7.1

Overview of permissible combinations and requirements ... 10

8

Illustration ... 11

9

Checks... 12

9.1

Visual checks ... 12

9.2

Function check ... 13

9.3

Service life ... 13

10

Use ... 14

10.1 10.1.1 10.1.2 10.1.3 10.1.4 10.1.5

Preparation / Commissioning ... 14 Adapter ... 14 Inserting the obturator in the cysto-urethroscope sheath ... 15 Inserting the telescope into the adapter ... 15 Inserting the adapter into the cysto-urethroscope sheath ... 16 Connecting the cysto-urethroscope to system components... 16

10.2 10.2.1 10.2.2 10.2.3 10.2.4 10.2.5

General notes and instructions for use... 16 Power ... 16 Irrigation / suction ... 17 HF application ... 17 Laser application ... 18 Inserting auxiliary instruments ... 19

11

Reprocessing and maintenance ... 20

11.1

Reprocessing sequence – Sheath... 23

11.2

Reprocessing sequence – Adapter ... 28

11.3

Reprocessing procedure – Obturator ... 32

12

Technical description... 35

12.1

Technical data ... 35

12.2

Usage, storage, transport, and shipping conditions ... 35

13

Spare parts ... 36

14

Disposal of product, packaging material and accessories ... 37

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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.

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1.2

Symbols

Symbols

Designation Follow the manual Medical device Product number Serial 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.

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2

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 Small-caliber cysto-urethroscopes are used primarily to show the lower urinary tract endoscopically / radiologically via the natural access or via an access created artificially if required for medical reasons.

Fig. 1

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4

Intended use Cystoscope sheaths 86720255

SHEATH FOR CYSTOSCOPE 12.5 FR.

86720455

SHEATH FOR CYSTOSCOPE 14.5 FR.

The products are used to access the operating field and for the supply and drainage of irrigation fluids. Cystoscope obturators 86720257

OBTURATOR FOR CYSTOSCOPE 12.5 FR.

86720457

OBTURATOR FOR CYSTOSCOPE 14.5 FR.

The products are used for atraumatic insertion of sheaths. Cystoscope adapters 8672265

ADAPTER FOR CYSTOSCOPE

The products are used for connecting sheaths to telescopes and for inserting auxiliary instruments.

User The product is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.

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Indications The products are used in lower and upper urinary tract urology for the following indications: n n n n n n n n

Lithotripsy (a) Foreign body removal in the bladder (b) Tumor removal in the bladder (c) Diagnostic cystoscopy (d) Incontinence therapy (e) Reflux therapy (f) Bladder neck incisions (g) Urethrotomy (h)

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)

86720255 SHEATH FOR CYSTOSCOPE 12.5 FR.

x

x

x

x

86720455 SHEATH FOR CYSTOSCOPE 14.5 FR.

x

x

x

x

8672265

x

x

x

x

ADAPTER FOR CYSTOSCOPE

(e)

(f)

(g)

(h)

x

x

x

x

x

x

x

x

x

x

x

Patient group The use of the products is restricted to patients with small anatomies. There are no restrictions with regard to ethnicity, sex, or weight. Before use, the attending physician must make sure that the product in view of its dimensions or settings can be used safely in the patient.

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Contraindications and side effects

6.1

Contraindications There are currently no known contraindications directly related to the products in urology. Medical contraindications for the aforementioned procedures, e.g., urinary tract infections, exclude the use of the products concerned.

6.2

Side effects When used as intended, there are no known side effects related to the products.

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Combinations CAUTION Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. n Combine the different products only if the intended use and the relevant technical data (working length, diameter, peak voltage, etc.) are the same. n Follow the instructions for use of the products used in combination with this product. n Observe the "Notes and instructions on HF applications", order no.: GA-S002 as well as the HF device manufacturer's instructions.

7.1

Overview of permissible combinations and requirements The products are used with: n n n n n n

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Endoscopic cameras and light sources Endoscopic devices Endoscopic instruments and accessories Surgical devices and accessories Laser fibers Suction and irrigation devices

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Illustration

Fig. 2 Item

Designation

Item

Designation

1

Telescope 30°

4

Adapter

2

Cysto-urethroscope sheath

4.1

Clamping handle

2.1

Sheath tip with window

4.2

Locking mechanism

2.2

Removable irrigation valve

4.3

Removable instrument port

2.2.1

Stopcock insert

4.3.1

Stopcock insert

2.2.2

Stopcock housing

4.3.2

Stopcock housing

2.2.3

Luer connector

4.3.3

Luer connector

2.2.4

Indicator for capacity [3.0 mm] on the: - Stopcock housing [3 dots] - Stopcock insert [3 bumps]

4.3.4

Indicator for capacity [4.2 mm] on the: - Stopcock housing [4 dots] - Stopcock insert [4 bumps]

2.3

Locking mechanism

4.4

Rubber cap

2.4

Tab with color coding

3

Obturator

#

Model no.

3.1

Handle

*

Capacity in Fr. / mm

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9

Checks WARNING Loss of sterility! In the case of a damaged sterile barrier system or if the date of expiry is exceeded, product sterility is no longer guaranteed. Unsterile products can cause infections. Open the sterile barrier system only directly before using the sterile product.

WARNING Injuries due to damaged or incomplete products! Injuries to the patient, user, and others are possible. Do not use the products if they are damaged and incomplete or have loose parts. Run through the checks before and after each use.

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 instruments and accessories for: ð Damage ð Sharp edges ð Loose or missing parts ð Rough surfaces 2. Any inscription, lettering, or labeling necessary for safe and correct use must be legible. 3. Replace the rubber cap (4.4) if it is damaged and brittle.

Fig. 3

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9.2

Function check 1. Check the compatibility of the individual components. 2. Check that the individual connections are fitted securely. 3. Check the easy mounting of the individual components. Replace the products if the connection does not hold or if it is difficult to assemble or screw together. 4. Check the image quality and light output. 5. Check that the auxiliary instruments can be easily inserted through the instrument port (4.3). 6. Check that the stopcock insert (2.2.1) / (4.3.1) can be felt to engage in the stopcock housing (2.2.2) / (4.3.2). 7. Switch on the irrigation system. 8. Check the irrigation and suction function. 9. Check the flow at the irrigation valve (2.2) and drain stopcock (2.5). ð Open the stopcock insert (2.2.1). ð Turn the stopcock insert (4.3.1) into the locked position. 10. Check the tightness of the irrigation valve (2.2), drain stopcock (2.5), and instrument port (4.3). ð Turn the stopcock insert (2.2.1) into the locked position. ð If the stopcock is not leak tight: Replace the stopcock insert (2.2.1) / (4.3.1). 11. Check that the stopcock insert (2.2.1) / (4.3.1) moves easily in the stopcock housing (2.2.2) / (4.3.2). 12. Check the entire system for leaks and continuity.

Fig. 4

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.

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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.

WARNING The product should only be used and brought to the surgical site under visual control and, if necessary, under X-ray control.

10.1

Preparation / Commissioning 1. Check assembly: see section 11.1 Reprocessing sequence – Sheath and 11.2 Reprocessing sequence – Adapter 2. Perform visual checks: see section 9.1 Visual checks

10.1.1

Adapter ¯ Position the rubber cap (4.4).

Fig. 5

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10.1.2

Inserting the obturator in the cysto-urethroscope sheath CAUTION Do not insert the cysto-urethroscope sheath (2) without the obturator (3). This may result in unintentional tissue damage. Only insert the cysto-urethroscope sheath atraumatically with the obturator (3) in place. Locking: 1. Insert the obturator (3) into the cysto-urethroscope sheath (2) so that the groove (a) and pin (b) lie on one plane. 2. Push together until the locking mechanism (2.3) automatically engages.

Fig. 6

NOTE If the locking mechanism (2.3) does not engage, press the tab (2.4) as far as it will go and repeat the process.

Releasing: ¯ Press the tab (2.4) and remove the obturator (2).

10.1.3

Inserting the telescope into the adapter The clamping handle (4.1) is in position "I". Locking: n

1. Insert the telescope (1) into the adapter (4). ð The pin (c) engages in the groove (d). 2. Turn the clamping handle (4.1) to position "II". ð Both components are locked together. n The clamping handle (4.1) is in position "II". Releasing: 1. Turn the clamping handle (4.1) to position "I". ð The locking mechanism (4.2) is unlocked. 2. Remove the telescope (1).

Fig. 7

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10.1.4

Inserting the adapter into the cysto-urethroscope sheath ¯ Follow the procedure described in section 10.1.2 Inserting the obturator in the cysto-urethroscope sheath.

Fig. 8

10.1.5

Connecting the cysto-urethroscope to system components 1. Connect the irrigation tube and drain tube to the irrigation valve (2.2) and drain stopcock (2.5), as well as to the irrigation system. ð Use the tube with LUER-LOCK connector (e) if necessary. 2. Connect the fiber light cable (f) to the cold light connection and connect to a suitable light source. 3. Perform function checks: see section 9.2 Function check

Fig. 9

10.2

General notes and instructions for use

10.2.1

Power WARNING Danger of electric shock! Patient leakage currents can accumulate if endoscopes are combined with powered accessories that can be used endoscopically. Ensure that the combinations do not exceed the approved patient leakage currents.

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10.2.2

Irrigation / suction WARNING Temperature increase when working without irrigation fluid! Mucosal injuries due to excessive temperatures put the patient at risk. Activate the electrodes and laser fibers only in the irrigation fluid and with continuous irrigation.

CAUTION Electrical conductivity due to irrigation fluid. The user must select the irrigation fluid subject to the application. It may only be slightly conductive. Do not use any NaCl solution with monopolar HF applications.

CAUTION Due to the different anatomical conditions, it is not possible to quantify the irrigation power and suction power. These must be adapted by the user to the respective conditions.

10.2.3

HF application WARNING There is a risk of injury if the HF instrument is not visible through the scope. Unintentional tissue damage as well as damage to the distal end of the endoscope and to the instrument parts are possible. Use HF instruments within the scope of the predetermined specifications (dielectric strength, operating mode). Do not activate HF instruments until the part conducting high-frequency current appears fully in the field of view of the cysto-urethroscope and the intended application area is being contacted.

WARNING Explosion hazard when the HF instrument is activated in an air or gas bubble (e.g., top of urinary bladder)! This results in injuries to the bladder wall. Do not activate the HF current until: ⊳ The HF instrument is in the field of view and in the irrigation fluid. ⊳ The desired tissue contact is achieved.

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WARNING Risk of HF arcing. Risk of injury if the distance between the part of the HF product conducting highfrequency current and the other conductive parts is too small. The parts of HF products conducting HF current must be at least 10 mm (safety distance) from other conductive parts when the HF current is activated. In the event of HF arcing, replace the HF instrument immediately, check the cysto-urethroscope for damage, and send it in for repairs if necessary to prevent subsequent damage.

Fig. 10

WARNING Excessive power setting in the sphincter region! Causes thermal damage and can lead to dysfunction of the sphincter. Brown / black coloration or carbonization of the tissue indicates excessive power. The depth effect (necrosis) is about 0.5 to 2 mm, depending on the power / mode of the electrode. Therefore, be especially careful near the sphincter and use the lowest possible HF power.

WARNING Incorrect selection of the HF output power! Injuries to the patient as well as damage to the product are possible. The power setting must be adjusted in accordance with the operator's experience/training with reference to the applicable indication.

10.2.4

Laser application WARNING Do not work outside of the field of view! Unintentional tissue damage as well as damage to the distal end of the cystourethroscope and to the instrument parts are possible. Do not activate the laser until: ⊳ the laser fiber tip appears fully in the field of view of the cysto-urethroscope and ⊳ the intended application area can be contacted using the pilot beam.

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WARNING Risk of eye damage when using without filter attachment. Use a suitable filter attachment on the cysto-urethroscope eyepiece.

ATTENTION Heat generation due to focused laser beam! The heat generated by the laser beam affects the stability of the instrument parts. Do not direct the laser beam at instrument parts, especially plastic parts. Maintain a sufficient safety distance.

NOTE When using lasers, you must observe the information from the laser device manufacturer and the general regulations for the use of lasers. You must wear the prescribed personal protective equipment.

10.2.5

Inserting auxiliary instruments WARNING Risk of injury when inserting auxiliary instruments if these are not visible through the scope. Unintentional tissue damage is possible. ⊳ Only insert the auxiliary instrument under visual control. ⊳ Only carry out manipulations if the auxiliary instrument appears fully in the field of view of the endoscope.

WARNING Risk of injuries and damage to the cysto-urethroscope when inserting and retracting forceps and scissors with the jaw sections open. Unintentional tissue damage, damage to the distal end of the cysto-urethroscope, and loss of particles on the jaw section are possible. ⊳ Only insert and retract forceps and scissors with the jaw section closed and under visual control.

ATTENTION Only use flexible auxiliary instruments in accordance with the capacity [see indicator on the cysto-urethroscope sheath (2)] and with a working length of at least 315 mm.

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11

Reprocessing and maintenance WARNING Danger of infection! The products and accessories are delivered in unsterile condition. If unsterile products are used there is the danger of infection for the patient, user and others. The products must be reprocessed at least once before their first use and before every further use. The user is obliged to make sure that the reprocessing process including the resources, materials and staff is suitable to achieve the required results.

WARNING Danger of transmitting microorganisms! To protect the service staff, only send in products for repair that have been reprocessed according to the latest state of the art in hygiene. n Adhere to the reprocessing sequence described in the instructions for use.

ATTENTION Risk of damage to the products if unapproved reprocessing procedures are used.

ATTENTION n

n

n

Use only cleaning agents and disinfectants whose efficacy and material compatibility with endoscopes and endoscopic accessories has been tested and approved by the chemicals manufacturer. ð Examples of suitable active agents for chemical disinfection: - Ortho-phthalaldehyde - Ethandial, didecyldimethylammonium chloride - Formacedal, glutardialdehyde - Sodium carbonate peroxyhydrate Disinfectants meeting the test criteria of the VAH (Association for Applied Hygiene R.S.), FDA or other national certification bodies may also be used Do not use disinfectants containing peracetic acid without corrosion protection, phenols or chlorine components for the reprocessing of RICHARD WOLF products.

NOTE Brand new products. Before reprocessing, remove all protection foils and transport locks from the products and accessories.

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