E-LINE Cystoscope 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 surrounding. 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

GA--D 361

Contents 1

Intended use...

1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1 5.2

Illustration... Legend and identification... Symbols...

2 2 2

6 6.1 6.1.1 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.3 6.4 6.4.1 6.5 6.6

Use... Preparation... Assembly of handle 8702.261 (optional)... Additional notes and instructions for use... Light... Current... Image quality... Irrigation fluid... Auxiliary instruments... Lithotripsy application... Additional instructions for laser lithotripsy... HF application... Laser application...

3 3 4 5 5 5 5 5 5 6 6 7 7

7 7.1 7.2

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

8 8 8

8 8.1 8.2 8.3 8.3.1 8.4 8.5 8.6 8.6.1 8.6.2 8.6.3

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Loading the reprocessing basket... Checks... Assembly before sterilization... Sterilization... Loading the reprocessing basket... Steam sterilization... STERIS and STERRAD sterilization procedures...

9 9 9 10 11 11 12 12 12 13 13

9

Technical data and order data... 14

10

Spare parts and accessories... 14

11 11.1

Operating, storage, transport and shipping conditions... 14 Disposal of product, packaging material and accessories... 14

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1

Intended use The Miniature Cysto--Urethroscope serves to visualize the lower urinary tract (urethra / bladder) via natural or surgically created passages.

2

Indications and field of use For examination, diagnosis and therapy in conjunction with endoscopic accessories, in the following applications: transurethral extraction or lithotripsy in newborn babies and infants tumor diagnostics removal of foreign bodies This product may only be applied by adequtely qualified and trained medical personnel.

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 Intracorporeal lithotripsy systems Suction and irrigation device Light source and fibre light cable Video camera and objective lens Endoscopic accessories: grasping forceps, stone extractors, probes, laser fibers, syringes 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, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product. The cold--light connector (8) can be unscrewed and replaced by suitable adapters to connect flexible light cables of other manufacturers (fig. 1). For order numbers please refer to the latest catalog sheet.

Fig. 1 8

25 25

8/ 9.8 Ch.

1

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Illustration

11

1

2 3

8

10

9

# 5

6

12

7

12.1 12.2

25

4.5/6.5 Ch.

4

14

13

16

15

Designation Objective lens Light exit Working channel Endoscope tip Sheath

Item 11 12 12.1 12.2 13

6

Size of endoscope tip in Fr.

14

7 8 9

Size of sheath in Fr. Cold--light connector Fiber core diameter in mm Color coding ring, blue Identifies the direction of view 12

15 16

Designation Eyepiece Automatic valve Membrane valve Valve holder Rubber cap Irrigation / drain stopcock with removable stopcock plug Identification: max. passage (insert capacity) in Fr. Identification: indication of direction of view

#

Product no.

Fig. 2 5.1

Legend and identification Item 1 2 3 4 5

10

5.2

Symbols Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order 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 Fig. 3 Check assembly (section 8.5) Firmly tighten the valve holder (12.2). Before tightening, check that a membrane valve (12.1) is in place. (fig. 3 a). Install the rubber cap (13). Perform a visual check (section 7.1)

Fig. 3 Fig. 3a

12.2

12.1 13

Fig. 4

3

Fig. 4 Connect the irrigation and drain tubes.

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Fig. 5

Fig. 5 Connect the fibre light cable. NOTE! To obtain optimum light transmission, the diameters of the fibre core of the endoscope and of the fibre light cable must be the same (fig. 5). Possible causes when using a fibre light cable that is too large: the coupling point with the endoscope may become excessively hot is too small: the light output is reduced For a suitable fibre bundle diameter please check the product number of the fibre light cable. the code number on the cold--light connector (8) must correspond with the two digits to the right of the decimal point of the product number. Exception: The fibre light cable 8061.933 has a fibre bundle diameter of 3.5 mm. CAUTION! Intense heat due to high light energy! In the case of unfavorable combinations, using the highly temperatureresistant fibre light cable 8063.353 can cause a temperature increase at the coupling point between the fibre light cable and the endosope. The user may get burns and the endocope can become damaged. Reduce the light output, if necessary use fibre light cable with product no. 8061.xxx / 8062.xxx.

6.1.1

Assembly of handle 8702.261 (optional) Fig. 6 1. Unscrew the locking collar (a). 2. Insert the ureteroscope proximally into handle 8702.261 as far as it will go. 3. Tighten the locking collar (a). The handle should be locked in place.

a

3

1 25

2

Fig. 6 For disassembly proceed in reverse order Perform a functional check (section 7.2)

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6.2

Additional notes and instructions for use IMPORTANT! During the operation an X -- ray device should be available for fluoroscopy control whenever required.

6.2.1

Light IMPORTANT! Use only products with BF type applied parts in conjunction with this 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 tissue due to soiling/contamination in the light exit area if high- performance light sources are used. Do not touch the light exit area and avoid direct contact with the tissue. Remove any soiling/contamination. WARNING! Fire hazard! Do not place the light exit area against heat- sensitive flammable surfaces (dark drapes etc.) as this can lead to excessively high temperatures or even ignition. Lay down the endoscope in a safe place. Switch off the light source if the endoscope will not be used for a period of time. CAUTION! Danger of burns! As a result of the high level of light energy at the cold- light connector, the connector is extremely hot when it is disconnected from the light source. Burns may result from unintentional contact with the connector. Do not touch the cold- light connector before it has cooled down.

6.2.2

Current WARNING! Danger of electrical shock! Patient leakage currents can add up if electrically powered endoscopic accessories or other electrically operated products are connected to and used with the endoscope! Check the combination before use.

6.2.3

Image quality CAUTION! Increased danger potential if image is blurred! Patient may be injured. Stop operation for safety reasons if image is blurred. Check image quality of endoscope before use (section 7.2).

6.2.4

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

6.3

Auxiliary instruments Select the auxiliary instruments you want to used in accordance with the passage size (capacity) and the working length of this product (see Technical data and order data, Section 9)

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6.4

Lithotripsy application IMPORTANT! Make sure you follow the probe manufacturer’s instructions. CAUTION! Discard kinked probes and probes with damaged insulation immediately. Interrupt the operation if necessary and replace the probe. Carefully check the probes before each use. CAUTION! Danger of injuring the patient when inserting the probes. If you push forward the probes too fast and incorrectly, there is the risk of perforating the ureter if the probe tips project from the endoscope. Carefully insert the probes under endoscopic control. CAUTION! Careful when working outside the scope’s field of view! Danger of perforating the ureter! Make sure you always keep the probe tip in the scope’s field of view to prevent mechanical perforation.

6.4.1

Additional instructions for laser lithotripsy When using lasers, make sure you observe the laser device manufacturer’s instructions as well as the general instructions on the use of lasers. Wear the required personal protection gear. CAUTION! Do not work outside the scope’s field of view! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts can occur. Activate the laser only after the tip of the laser fiber has become fully visible through the endoscope and the area to be treated makes contact by means of the pilot beam CAUTION ! High temperatures due to highly coherent laser beam ! The heat generated by the laser beam reduces the strength of instrument parts. Do not direct the laser beam at instrument parts, in particular not at plastic parts. Keep a safe distance. CAUTION ! Danger of eye injury when using lasers without filter attachment ! Use a suitable filter attachment on the endoscope eyepiece.

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6.5

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 to instrument parts is possible. HF instruments should therefore be used only within the scope of their specifications as to electric strength, mode of operation. Activate HF instruments only if the live HF part is fully visible through the scope and in contact with the target tissue.

WARNING! HF arcing! 10mm

Danger of injury from HF applications which do not fulfill the intended use or in the case of insufficient distance between live parts of HF instruments and other conductive parts! When activated, live high- frequency parts of HF instruments must be kept at a safe distance of at least 10 mm from the distal end of the spatula or tube, respectively (Fig. 7).

Fig. 7

CAUTION! Take care when selecting the HF output power. Do not use excessive HF output power! The patient may be injured and the product may become damaged. The power must be set in accordance with the experience and/or training of the surgeon with regard to the respective indication.

6.6

Laser application Make sure you observe the same rules and instructions as stated under section 6.4.2 Additional instructions for laser lithotripsy.

7

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Checks CAUTION! Be careful if products are damaged or incomplete. Possible injury of patient, user or third person. 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

12.1

13

Fig. 8

7.2

Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Check in particular the instrument tip (4) for damage to avoid traumata of the ureter(s). Check the rubber cap (13) and the membrane valve (12.1) for perfect working order and replace the caps or valves (see fig. 8). 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.

Functional check Check that all parts of the Cysto--Urethroscope move easily in assembled condition. Check the suction and irrigation flow before each use. Check image quality and light output: Deposits on the glass surfaces can cause a stained or blurred image and can considerably impair light transmission. Clean glass surfaces with a swab soaked with alcohol (use wooden stick, not metal or plastic), wipe difficult--to--remove deposits with instrument cleaner* (Fig. 9).

*see manual GA--J020 “Reprocessing of RICHARD WOLF Heat Stable Instruments ”. Fig. 9

Hold the distal end of the endoscope towards a light source. When looking at the cold--light connector (8), broken fibers appear as dark spots. If more than 30% of the fibers are broken the light output is no longer sufficient (Fig. 10).

Fig. 10 8

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8

Reprocessing and maintenance IMPORTANT! Further information on the reprocessing is described in Manual GA--J020 “Reprocessing of RICHARD WOLF Heat Stable Instruments” and these instructions must be followed. Removable stopcock plugs! For this, follow BB--J020 “Reprocessing of stopcocks with removable levers”.

8.1

Disassembly before cleaning Fig. 11 Unscrew the cold--light connector (8). Unscrew the valve holder (12.2). Remove the rubber cap (13). IMPORTANT! Replace the membrane valve (12.1) after each use. Remove the membrane valve (12.1). Use O--Ring tool.

Fig. 11

8

12.1 12.2

13

25 25

8.2

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

9

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8.3

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning: see section 8.1 Machine cleaning / disinfection First, clean the valve holder (12.2) and the internal thread manually. Ensure that the endoscope and the injection cannula are rinsed out in the washer via the luer fitting. NOTE! For connection to the washer, screw on the valve holder (12.2) without a membrane valve (12.1), see fig. 16.

Fig. 12

12.1

12.2

25 25

8/ 9.8 Ch.

NOTE! To prevent damage during reprocessing we recommend using a suitable reprocessing basket (see Spare parts and accessories, section 10).

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8.3.1

Loading the reprocessing basket (fig. 13) Open locking mechanism (20.2). The basket lid (20.1) will open. Raise the basket lid (20.1) and lift off. Screw the valve (12) into the Cysto--Urethroscope. First, manually pre--clean the contact surfaces and thread of the Cysto--Urethroscope. Place the parts used onto/into the corresponding holders (20.5) provided: Miniature--Cysto--Urethroscope with valve Cold--light connector (8) Place the following parts into the utensils basket (20.6): Sealing cap (13) Stopcock plug (14.1) Route the rinsing tube through the grid holes and connect all connections and fittings. Engage hook (20.3) into the lower basket (20.4) and close the basket lid (20.1).

Fig. 13

20.1

20 20.2

20.3

14.1 13

20.6

8

= Rinsing tube

8.4

20.4

20.5

12

Checks Perform a visual check (see section 7.1)

11

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8.5

Assembly before sterilization Fig. 14 Loosely screw on the cold--light connector (8). Place a membrane valve (12.1) into the valve holder (12.2) . Loosely screw on the valve holder (12.2) with a membrane valve (12.1) in place (minimum 2 turns open). NOTE! Before sterilization screw on the screw connections only loosely to allow a sufficient flow of sterilization medium. to avoid stress cracks. Tighten all screw connections before use.

Fig. 14

8 12.1

12.2

25 25

8/ 9.8 Ch.

8.6

Sterilization

8.6.1

Loading the reprocessing basket (fig. 15) Open locking mechanism (20.2). The basket lid (20.1) will open. Raise the basket lid (20.1) and lift off. Place Miniature--Cysto--Urethroscope into the corresponding holder (20.5). Engage hook (20.3) into the lower basket (20.4) and close the basket lid (20.1).

Fig. 15

20.1

20 20.2

20.3 20.5 20.4

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IMPORTANT! When loading the sterilizer, follow the sterilizer manufacturer’s instructions. Do not overload the sterilizer. For sterilization, wrap the reprocessing basket/tray in a special wrapping complying with the standards in your country, e.g. EN 868, or use a suitable sterilization container. 8.6.2

Steam sterilization Steam sterilization at 134°C (273°F) using the fractional prevacuum method.

8.6.3

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.

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Technical data and order data

10

Product/ Model/type no.

Endoscope tip/ Sheath tube

Direction of observation

Direction of view

Working length

Max. lumen

8715401

4.5 / 6.5 Fr.

lateral

5

120 mm

3 Fr.

Spare parts and accessories Illustration

Model/ type no. Designation, Technical data 38044.611 REPROCESS BASKET height x width x length 472x132x74 mm, weight approx. 0.8 kg 15 256.393

--

Valve holder (olive) (item 12.2)

89.101

SEAL Ø 7.5MM (Item 12.1) 10/pkg (yellow)

88.005

RUBBER CAP CAP 0.5MM, red, 0.5 mm passage, 10/pkg for instruments up to 5 Fr.

886.00

LUER LOCK CONNECTOR

8095.00

ADAPTER ENDOSCOPE SIDE

15 106.230

O--ring tool

7321.911

CLEANING BRUSH Ø 2.5MM TL 1000MM

103.00

BELLOWS PUMP

8702.261

HANDLE FOR E--LINE URETERO RENOSCOPES

15009.240

Locking collar for handle 8702.261

15 256.456

Valve holder (luer)

896.0002

STOPCOCK BNDL CAP 3.0MM Identification: 3 pegs Packaging unit = 5/pkg

38310.0001

DISASSEMBLY TOOL

828.03 829.03 824.03

FLEX. GRASP. FORCEPS 3FR WL 230MM FLEX. BIOPSY FORCEPS 3FR WL 230MM 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.

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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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