Miniature Compact Fiber Cysto--Urethroscope Instructions manual

Important general instructions for use Ensure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Use this product only with the combinations and with the accessories and spare parts listed in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for this use and if the performance and safety requirements are met. Reprocess the products before every application and before returning them for repair as required by the instruction manual in order to protect the patient, user or third parties. Subject to technical changes! Due to continuous development of our products, illustrations and technical data may deviate slightly from the data in this manual. CAUTION -- USA only: Federal law restricts this device to sale by or on the order of a physician.

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

Intended use...

1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

2 2

6 6.1 6.1.1 6.2 6.2.1 6.2.2 6.2.3 6.3 6.4

Use... Preparation... Assembly of insertion port stopcock... Additional notes and instructions for use... Light... Strom... Irrigation fluid... Auxiliary instruments... HF application...

3 3 3 4 4 5 5 5 5

7 7.1 7.2

Checks... Visual check... Functional check...

6 6 6

8 8.1 8.2 8.3 8.4 8.5 8.6 8.6.1 8.6.2

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Gas sterilization... Steris and Sterrad sterilization procedures...

7 7 7 7 7 7 8 8 8

9

Technical data and order data...

9

10

Spare parts and accessories...

9

11 11.1

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

9 9

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I

1

Intended use The Miniature Compact Fiber Cysto--Urethroscope is used to visualize the urethra and bladder through the natural passage.

2

Indications and field of use Examination, diagnosis and therapy of the lower urogenital tract in newborn infants and small children in conjunction with endoscopic accessories.

3

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.

4

Combinations The Miniature Compact Fiber Cysto--Urethroscope can be combined with Suction and irrigation device Light source and flexible light cable Video camera and objective lens Auxiliary instruments up to 2.4 Fr. Needle electrode 824.03 CAUTION ! Be careful if products are incorrectly combined ! Injury may result to the patient, user or others, and damage may result to the product. Different products should only be used in combination 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 product. The cold--light connector (1.6) can be unscrewed and replaced by suitable adaptors to connect flexible light cables of other manufacturers. (Fig. 1) For the order number please refer to the latest catalog sheet.

1.6

Fig. 1

1

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5

Illustration

1.1 1.2

1.7 1.4

1.3

1.8

1.6

1.5

1.10

1

1.9 1.13

1.14

2 2.2

1.10

2.3 1.11

1.12

5.1

#

Legend and identification Item

Designation

Item

Designation

1

Miniature Compact Fiber Cysto--Urethroscope

1.1

Objective lens

1.9 1.10 1.11

Irrigation supply stopcock Drain stopcock Threaded connector

1.2

Light exit

1.12

Identification: direction of view

1.3

Working channel

1.13

Identification: passage 2.4 Fr.

1.4

Endoscope tip

1.14

Identification: sheath size 4.5/6 Fr.

1.5

Sheath tube

2

Insertion port stopcock

1.6

Cold--light connector

2.1

O--ring (see page 7,8)

Colored ring, blue: Identification of direction of view 0

2.2 2.3

Locking collar Rubber cap

Eye cup

#

Product no.

1.7 1.8

Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Series number 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).

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6

Use CAUTION! The products have only limited strength! Exerting 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. Ensure that no missing instrument parts remain in the patient. Do not use products which are damaged, incomplete or have loose parts.

6.1

Preparation Perform a visual check (Section 7.1)

6.1.1

Assembly of insertion port stopcock

2.3

Install rubber cap (2.3) (Fig. 1).

Fig. 1 Hold the insertion port stopcock (2) against the threaded connector (1.11). The guide nose (a) must engage in the groove (b). Tighten the locking collar (2.2) in the direction indicated by the arrow.

b

a 2.2

Fig. 2

3

1.11

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Connect the irrigation supply and drain tubes (A) to the irrigation supply stopcock (1.9) / drain stopcock (1.10). (Fig. 3) Connect the fiber light cable (B) to the cold--light connector (1.6). (Fig. 3)

B

1.6

A Fig. 3

1.10

NOTE ! For optimum light transmission, the fiber bundle diameters of the endoscope and of the fiber light cable should be the same. If a fiber light cable with excessive diameter is selected, the coupling point of the endoscope may get excessively hot. If a fiber light cable with a small cross--section is selected, the light output is reduced. CAUTION ! Heat may be generated due to high light energy! If the high- temperature- resistant fiber light cable 8063.353 is used, under unfavorable conditions, a temperature increase at the coupling point between the fiber light cable and the endoscope may occur. This may lead to burns to the user and damage to the endoscope. Reduce the light output. We recommend using fiber light cable 8061.16/.163. Perform a function check (Section 7.2)

6.2

Additional notes and instructions for use

6.2.1

Light IMPORTANT ! Use only products with Type BF applied parts in conjunction with the endoscope. WARNING ! Heat may be generated due to high light energy! Danger of unintentional tissue damage due to insufficient distance between the light exit area and the tissue. Do not touch the light exit area and avoid direct contact with the tissue. WARNING! Fire hazard! Do not lay down the endoscope onto heat- sensitive flammable surfaces (such as dark drapes, etc.) as the heat generated at the light exit area can lead to excessively high temperatures or even ignition. Lay down the endoscope at a safe place. Switch off the light source if the endoscope will not be used for a period of time.

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6.2.2

Strom WARNING ! Danger of electric shock! Patient leakage currents can add up if the endoscope is combined with electrically powered products or combined with endoscopic accessories and used in this combination. Check the combination.

6.2.3

Irrigation fluid CAUTION ! Irrigation fluid can be electrically conductive! The user must choose a low- conductivity irrigation fluid suitable for the application. Do not use NaCl (saline) for HF applications!

6.3

Auxiliary instruments CAUTION ! Danger of injury if the auxiliary instrument is not within the surgeon’s field of view! Inadvertent tissue damage as well as damage to the distal end of the endoscope are possible! Insert the auxiliary instrument only under visual control. Carry out manipulations only after the auxiliary instrument has become fully visible through the scope. Choose the auxiliary instruments to be used in accordance with the size of the passage and the working length (see technical data and order data, Section 9).

6.4

HF application Make sure you observe the “Instructions and notes on HF applications”, order no.: GA--S 002, as well as the HF device manufacturer’s instructions. WARNING ! Danger of injury if the HF instrument is not visible through the scope! Inadvertent tissue damage as well as damage to the distal end of the endoscope and the instrument parts is possible. Activate HF instruments only if the live high- frequency part is fully visible through the endoscope and in contact with the area to be treated (Fig. 12).

10mm

Fig. 4

5

WARNING ! HF arcing! Danger of injury due to incorrect HF application and insufficient distance between the live HF instruments and other conductive parts. Live high- frequency parts of HF instruments must be kept at safe distance of at least 10 mm from the distal end of the endoscope (Fig. 4) when they are activated.

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7

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

7.1

Visual check Check the instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Check the rubber cap (2.3) for damage and replace, if necessary. Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identification which may lead to wrong handling and reprocessing must be restored.

7.2

Functional check Check the cysto--urethroscope in assembled condition for easy operation. Check the suction and irrigation performance before each application. Check the image quality and light output: Any deposits on the glass surfaces may result in a spotted or blurred field of vision and can considerably impair light transmission. Clean the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic), remove hard--to--remove deposits with instrument cleaner * (Fig. 5).

*For this, see also the “Notes and instructions on the reprocessing of Richard Wolf products, accessories and devices”, order no.: GA--J 020.

Fig. 5

Hold the distal end of the endoscope towards a light source. Broken fibers appear as black dots in the cold--light connector (1.6).If 30% of the fibers are broken, the light output is no longer sufficient (Fig. 6).

1.6

Fig. 6

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6

8

Reprocessing and maintenance IMPORTANT! Follow the current ”Notes and instructions on the reprocessing of Richard Wolf products, accessories and devices”, order no.: GA--J 020. Do not use disinfectants containing peracetic acid without corrosion protection agents, phenols or chlorine components for the reprocessing of Richard Wolf products. Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used. Removable stopcock plugs (levers)! For this purpose, please follow BB--J 020 ”Reprocessing of Stopcocks with Removable Levers”.

8.1

Disassembly before cleaning Unscrew the cold--light connector (1.6). Remove the rubber caps (2.3). Unscrew the insertion port stopcock (2). Remove the O--ring (2.1).

1.6

2.1

2.3 2

Fig. 7 8.2

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning: see section 8.1 Manual cleaning / disinfection

8.3

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning: see section 8.1 Machine cleaning / disinfection

8.4

Checks Perform a visual check (see section 7.1)

8.5

Assembly before sterilization NOTE!

1.6

Before sterilization screw on screw connections only loosely to allow a sufficient flow of the sterilization medium Tighten all screw connections before use. Screw on the cold--light connector (1.6) only loosely (Fig. 8).

Fig. 8 NOTE! Attach the insertion port stopcock (2) only after sterilization!

7

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Install the O--ring (2.1).

2.1

Fig. 9 8.6

Sterilization CAUTION! The Miniature Compact Fiber Cysto- Urethroscope cannot be steam- sterilized!

8.6.1

Gas sterilization Ethylene oxide gas (EO). Gas sterilization using formaldehyde gas (FA).

8.6.2

Steris

and Sterrad

sterilization procedures NOTE! The Steris and Sterrad sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility. For information about possible limitations, such as discoloration of plastic materials, as well as further notes see the latest version of ”Notes and instructions on the reprocessing of Richard Wolf products, accessories and devices”, order no. GA--J 020. Efficacy has been certified by the sterilizer manufacturers in microbiological tests. Follow the manufacturer’s instructions. NOTE! Steris sterilization procedure: Connect all channels to the system to ensure thorough reprocessing of all hollow spaces by the reprocessing medium. Follow the manufacturer’s instructions.

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9

Technical data and order data

10

Product number

Endoscope tip / Sheath tube

Direction of view

Working length

Working channel

4615.401

4.5 Fr./ 6 Fr.

0

110 mm

2.4 Fr.

Spare parts and accessories Illustration

--

Model/ type no. Designation, Technical data 8954.765

Insertion port stopcock

15 364.007

O--ring for insertion port stopcock (Item 2.1)

886.00

LUER LOCK CONNECTOR

103.00

BELLOWS PUMP

8095.00

ADAPTER ENDOSCOPE SIDE

88.01

RUBBER CAP CAP 0.8MM (10/pkg)

88.005

RUBBER CAP CAP 0.5MM (10/pkg)

824.03

NEEDLE ELECTRODE MONO 2.4FR WL 260MM

The products can be combined as required provided the relevant technical data and intended uses are observed. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard Wolf or your Richard Wolf representative.

11

Operating, storage, transport and shipping conditions Operating conditions

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

Storage, transport and shipping conditions

-- 20°C to +60°C , 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 observe the regulations and laws valid in your country. For further information please contact the manufacturer.

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