Dilation Instruments Instruction Manual

Important general notes and instructions for use Ensure that this product is used only as intended and described in this instruction manual, by ad­ equatelytrained 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.

Safety instructions and levels of danger Symbol

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.

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

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: +1 84 79 13 11 13 Telefax: +1 84 79 13 14 88 sales&[email protected] www.richardwolfusa.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 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 1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.at

[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

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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

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Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4

Contraindications...

1

5

Combinations...

1

6 6.1

Illustration... Symbols...

2 2

7 7.1 7.2 7.3 7.4

Application... Preparation... Application of telescope dilator 8955.xxx... Application of bougie 8962.249... Application of dilation guide rod 8962.19...

3 3 3 3 4

8 8.1

Checks... Visual check...

4 4

9 9.1 9.2 9.2.1 9.2.2 9.2.3

Reprocessing and maintenance... Reprocessing procedure... Low-temperature sterilization... Hydrogen peroxide plasma... Gas... Peracetic acid...

5 5 7 7 7 7

10

Technical data and order data...

7

11 11.1

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

7 7

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1

Technical description Flexible metal bougies with proximal handle Telescope dilator centrally hollow dilator with proximal stop centrally hollow guide rod with distal olive Dilation guide rod 8962.19 centrally hollow guide rod with atraumatic head Bougie 8962.249 with proximal handle with graduation

2

Intended use

The instruments are used for dilating and expanding surgically created or natural passages to body cavities (e.g. transurethrally or nephrostomy). Flexible metal bougies are used e.g. for dilating the ureter. Telescope dilators are used for dilating the puncture channel (nephrostomy), in particular for dilating transcutaneous punctures to reach a size suitable for passing endo­ scopes and the corresponding accessories. Dilation guide rod 8962.19 is used as an access guide for an existing or surgically created passage, for inserting a second guide wire or for introducing further bougies, e.g. - for passing a guide wire - for housing bougies in order to dilate percutaneous passages in hollow or­ gans Bougie 8962.249 is used for inserting a second guide wire, to be used via a 15 Fr. dilator.

3

Indications and field of use

For diagnosis and therapy of the upper urogenital tract (ureter/kidney). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.

4

Contraindications

5

Combinations

Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. For further notes and instructions please refer to the latest medical literature.

CAUTION! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product is possible. Combine the different products only if their intended uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this prod­ uct.

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6

Illustration Illustration

Designation

Product no.

TELESCOPE DILATOR (set) consisting of:

DILATOR 6FR (1)

8955.06

TELESCOPE DILATOR 9-18FR (4)

8955.185

TELESCOPE DILATOR 9-27FR (7)

8955.27

DILATOR 9FR for two guide wires

BOUGIE 24FR to be used over 15 Fr. dilator

DILATOR 30FR fitting over 27 Fr. dilator from 8955.27

6.1

8962.19

8962.249

8955.308

BOUGIE 10FR WL 600MM

8591.90

BOUGIE 12FR WL 600MM

8591.92

BOUGIE 14FR WL 600MM

8591.94

Symbols Symbol

Designation Attention, Caution

Follow the instruction manual

REF

Order no.

LOT

Lot designation

SN

Serial no. Identification in conformity with EEC directive 93/42/EEC on medical products, is only valid if the pro­ duct and/or its packaging is provided with this identification. 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 no. of the notified body (0124).

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7

Application CAUTION! The products have only limited strength! Applying 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

7.2

Application of telescope dilator 8955.xxx

Run through the checks: see section 8 Introduce the guide rod together with the size 9 dilator over the guide wire which is still in the nephrostomy channel, under x-ray control until the tip is placed in the renal pelvis. Introduce the other dilators one after the other up to the required diameter, by turning them while pushing them forward, the guide rod serving as an abut­ ment. Insert the sheath over the next smaller dilator. e.g.: insert a 27 Fr. sheath over a 24 Fr. dilator. Remove the dilators with the guide rod through the sheath. Introduce the endoscope via the guide wire which remained in situ until the stone is visible through the scope.

7.3

Application of bougie 8962.249 IMPORTANT! This bougie does not have any proximal or distal stop. Place the bougie only under x-ray control. The bougie must be used via a 15 Fr. dilator (telescope). Create a nephrostomy channel and dilate to the required final diameter as usual. Remove excess dilators. Place the bougie over the remaining 15 Fr. dilator including guide rod and guide wire under x-ray control. Place the second guide wire (safety wire) through the bougie. Remove the dilator and the bougie. The two wires remain in situ. Place the nephroscope sheath with centrally hollow obturator over one of the two wires. For the duration of the operation, the second wire automatically remains near the sheath as a safety wire in order to be used as a path finder should the sheath be left inadvertently.

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7.4

Application of dilation guide rod 8962.19 Puncture the renal pelvis. Place the guide wire. Dilate as usual up to approx. 9-12 Fr. using flexible bougies. Insert the guide rod over the guide wire remaining in situ. Apply telescope bougies as of 12 Fr. up to the required size. Place the second guide wire (safety wire). Remove the guide rod and the bougies. The two wires remain in situ. Place the nephroscope sheath with centrally hollow obturator over one of the two wires. For the duration of the operation, the second wire automatically remains near the sheath as a safety wire in order to be used as a path finder should the sheath be left inadvertently.

8

Checks CAUTION! Be careful if products are damaged or incomplete! Injuries of the patient, user or others are possible. Run through the checks before and after each use. Do not use the products if they are damaged, incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself.

8.1

Visual check

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Check instruments and accessories for damage sharp edges loose or missing parts rough surfaces Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible inscriptions and labels that can lead to wrong handling and reprocessing must be reinstated.

4

9

Reprocessing and maintenance

9.1

Reprocessing procedure

In the following information brochure the validated reprocessing methods for the individual product are described.

IMPORTANT! Due to the product design and the materials used it is not possible to define a specific limit of the maximum permissible reprocessing cycles. The life cycle of medical products is defined by their function and gentle handling. Before defective products are returned for repair, they must have gone through the entire reprocessing cycle. The user is obliged to make sure that the reprocessing process including the ressources, material and personnel is suited to reach the required reprocessing results. The state of the art and national laws require that validated processes be fol­ lowed. IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-Stable Instruments", and these must be followed.

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Product:

Instruments for Dilation

Reprocessing guide: Preparation at the point of use:

Directly after use, remove any coarse dust from the instruments. If more than 6 hours have elapsed between use and reprocessing, rinse out the hollow spaces of the instrument with a 5 ml syringe filled with water. Do not use any fixing or setting agents or hot water (>40°C) as this will bake the residues to the surfaces and may have a negative impact on cleaning.

Transport:

Safe storage, transport and shipment of the instruments to the reprocessing room in a closed container to prevent dam­ age to the instruments and contamination of the environment.

Precleaning:

Rinse out instruments for 20 seconds or, in pulsed mode, with 5 pressure surges (3 - 4 bar) using a water cleaning gun.

Cleaning:

Manual cleaning

Machine cleaning

1. Brush with a soft brush for at least 5 seconds to remove 1. Before machine cleaning, manually pre-clean the in­ any residues. struments. 2. Rinse out narrow channels with a syringe filled with 2. Place the instruments in a sieve tray of the washer / dis­ cleaning solution. infector. 3. Immerse in a cleaning solution for at least 5 minutes. Vario-TD program (without disinfection cycle): Before, the channels of the instruments must be 4 min of pre-cleaning with cold water filled with this solution. Empty 4. At the end rinse out instruments thoroughly for at least 6 min of washing with cleaning agent at 55°C 20 seconds or in pulsed mode with 5 pressure surges Empty (3 - 4 bar) using a cleaning gun. 3 min of neutralization*) (>40°C) Empty 2 min of intermediate rinsing with warm tap water (>40°C) Empty *) depending on the quality of the neutralization solution, add an acid based on citric acid. Disinfection:

1. Immerse instruments in an approved disinfectant solu­ Carry out thermal machine disinfection following the na­ tion, for exposure time refer to the manufacturer's in­ tional requirements regarding the A0 value (see DIN EN structions. ISO 15883). Before, the channels of the instruments must be filled with this solution. 2. At the end rinse out instruments thoroughly for at least 20 seconds or in plused mode with 5 pressure surges (3 - 4 bar) with water.

Drying:

Manual drying: Dry outside of instruments using a sterile lint-free dispos­ able cloth or swab, dry any hollow spaces with filtered compressed air (pulsed with 5 pressure surges; 3 - 4 bar).

Function check, maintenance:

Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the instrument appears visu­ ally clean. Carry out a visual check: see section 8.1

Packaging:

Wrap instruments for sterilization as required by the standard.

Sterilization:

Sterilization of products using the fractional pre-vacuum method (ISO13060/ISO17665) taking into account the cor­ responding national requirements. Temperature exposure time:

4 min at

Drying time: Maximum sterilization temperature:

10 - 20 min 138°C

Drying of instruments using the washer / disinfector drying cycle. If necessary, additional manual drying can be achieved us­ ing a sterile lint-free disposable cloth or swab. Dry hollow spaces with filtered compressed air.

134°C +4°C (273°F +7°F) 132°C +4°C (270°F +7°F)

Storage:

Store the sterilized instruments in a dry, clean and dust-free environment at moderate temperatures of 5°C to 40°C.

Validation:

The following test instructions, materials and machines were used during validation: Machine cleaning agent: alkaline cleaning agent 0.5% neodisher FA (Dr. Weigert) Manual cleaning agent: enzymatic cleaning agent 0.5% neodisher MediClean (Dr. Weigert) Manual disinfectant: Cidex (Advanced Sterilization Products) Automatic washer / disinfector: Miele G 7735 CD Washer / disinfector rack: Miele E 440/1

Additional instructions:

The user is obliged to validate his process in accordance with DIN EN ISO 17664.

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9.2

Low-temperature sterilization IMPORTANT! The low-temperature procedures using hydrogen peroxide and peracetic acid are approved for endoscopes and endoscopic accessories with regard to their mater­ ial compatibility. By no means must these low-temperature methods be used alternately. Possible interaction between these sterilization processes can cause damage to the instruments..

9.2.1

Hydrogen peroxide plasma STERRAD 50 / 100S / 200 / NX PLASMASTER 40 / 80 / 140

9.2.2

and 100 NX

Gas Ethylene oxide gas (EO) Formaldehyde gas (FA) Hydrogen peroxide (V-PRO™1)

9.2.3

Peracetic acid STERIS SYSTEM 1 / STERIS SYSTEM 1E

10

Technical data and order data See section 6 "Illustration" The products can be combined as required provided the relevant technical data and intended uses are obser­ ved. For the total overview please refer to the latest catalog sheets and brochures or contact Richard Wolf or your representative.

11

Operating, storage, transport and shipping conditions Operating conditions

+10ºC to +40ºC, 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

- 20ºC to +60ºC, 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

11.1

Disposal of product, packaging material and accessories For the disposal follow the relevant regulations and laws valid in your country. For further information please contact the manufacturer.

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