Wolf-Esophagoscopes 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

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

2

4

Contraindications...

2

5

Combinations...

2

6 6.1 6.1.1 6.2 6.2.1 6.3 6.3.1

Illustration... Esophagoscope model “Wolf”... Legend and identification... Esophagoscope for children... Legendand identification... Accessories... Legend and identification...

3 3 3 4 4 5 5

7 7.1 7.1.1 7.1.2 7.1.3 7.1.4 7.2 7.2.1 7.2.2 7.2.3 7.3 7.4

Use... Preparation... Inserting the proximal lighting insert... Connecting / disconnecting fiber light cable... Connecting the double blower... Attaching the handle... Additional notes and instructions for use... Light... Current... Image quality... HF application... Laser application...

6 6 6 7 7 8 8 8 8 8 9 9

8 8.1 8.2

Checks... 10 Visual check... 10 Functional check... 10

9 9.1 9.2 9.3 9.4 9.5 9.6 9.6.1

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steam sterilization...

10

Technical data and order data... 12

11

Spare parts and accessories... 12

12 12.1

Operating, storage, transport and shipping conditions... 12 Disposal of product, packaging material and accessories... 12

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I

1

Technical description Esophagoscope tube model “Wolf” Tube with graduation Connecting piece for attaching a handle Connecting piece for proximal lighting insert Stopper Cold light connector Integrated light guide Luer fitting Adaptor (cone) for accessories Esophagoscope tube for children Tube Connecting piece for proximal lighting insert Irrigation stopcock Adaptor (cone) for accessories

2

Intended use Esophagoscopes are used for endoscopic visualization of the esophagus via the natural passage. The auxiliary instruments used in combination with this scope such as forceps and scissors are used for grasping, manipulating, cutting as well as dissecting and removing tissue parts or foreign bodies, or taking smears. HF auxiliar instruments are used for tissue and vessel coagulation as well as for cutting by means of high frequency current. Coagulation suction tubes are used for suction and irrigation. Telescope serves to visualize body cavities. Esophagoscope tube access to the operating area / keeping the surgical passage open, for insertion of auxiliary instruments, for insufflating air in the esophagus via the luer fitting / stopcock. Adjustable telescopic magnifier is used in conjunction with the esophagoscope tube to obtain a magnified view of the operating area. Universal closure cap is used as a proximal attachment to the esophagoscope tube and has the following positions: -- closure with glass window. -- seal with rubber cap. -- free passage (only in case of universal closure cap for esophagoscope tube for children). Closure cap with sealing cap proximal closure for esophagoscope tube for children in conjunction with telescope or instrument. Closure cap with viewing window is used for closing the esophagoscope tube proximally. Proximal lighting insert proximal lighting option with cold light connector. Handle to facilitate handling. Magnetic extractor serves to remove ferromagnetic foreign bodies. Threaded extractor is used to extract soft foreign bodies that are difficult to grasp. Swab carrier instrument / cotton carrier for compression of hemorrhages and the taking of swabs / smears.

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Indications and field of use For examination, diagnosis and / or therapy of the esophagus in case of suspected foreign bodies supected tumor unclear difficulties swallowing in the area of the esophagus checking after chemical burns suspected stenosis unclear hemorrhages.

4

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.

5

Combinations Esophagoscopes are used in conjunction with: light sources and fiber light cables esophagoscope telescopes HF surgical devices endoscopic accessories: such as optical forceps, rigid forceps, instruments for suction and irrigation etc.

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. Follow the information in the leaflet “Overview of permissible combinations” BB- G 133. Fig. 1 the cold light connector (3.1) can be unscrewed and replaced by suitable adaptors to connect fiber light cables made by other manufacturers. For order data please refer to the latest catalog sheets.

3.1 Fig. 1

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6

Illustration

6.1

Esophagoscope model “Wolf”

1 7.1

7

2.5 2.4

2 40

45

5

2.2 2.3

2.1

4.1

8.1

4

6

3.1

8

3

6.1.1

Legend and identification Item 1

3

Designation Esophagoscope telescope

Item 5

Designation Adjustable telescopic magnifier

2

Esophagoscope tube

6

Closure cap with observation window

2.1

Connecting piece for lighting insert (3)

7

Universal closure cap

2.2

Luer fitting

7.1

Sealing cap

2.3

Luer sealing cap

8

Handle

2.4

Connecting piece for handle

8.1

Locking screw

2.5

Cold light connector

3

Proximal lighting insert

3.1

Cold light connector

4

Stopper

4.1

O--ring

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6.3

Accessories

10

11

12

13

6.3.1

Legend and identification Item

Desigantion

Item

Designation

10

Magnetic extractor

12

Swab carrier instrument

11

Threaded extractor

13

Cotton carrier

Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Series number CE marking in compliance with directive 93/42/EEC on medical products. Is only valid if the product and/or packaging is identified with this marking . Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally identified with the 4­digit code number of the notified body. The CE marking on the title page of this instruction manual relates exclusively to the Richard Wolf main product or, if several equivalent products are described, to the Richard Wolf product with the highest classification. The CE marking of the other Richard Wolf products described in this manual and of other manufacturers, if applicable, results exclusively from the identification on the product and/or its packa­ ging.

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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.

7.1

Preparation Run through the checks: chapters 8 and 8.1 Screw on luer closure cap (2.3). Install sealing caps (7.1/9.1).

7.1.1

Inserting the proximal lighting insert NOTE ! During insertion, adjustment or removal, make sure that the proximal lighting insert (3) won’t fall down and be damaged. Figure 1: Insert the proximal lighting insert (3) into the connecting piece ( 2.1) as far as it will go, notch (a). Slowly push back the proximal lighting insert (3) from notch (a) to notch (b). Insert the esophagoscope telescope (1) / auxiliary instrument.

2 1

2.1

a b 3

fig. 1

Adjust the proximal lighting insert (3) from notch (b) to notch (a) (fig. 2).

a b 3 fig. 2 Removing the esophagoscope telescope (1) / auxiliary instrument Carefully push back the proximal lighting insert (3) from notch (a) to notch (b). Remove the esophagoscope telescope (1) / auxiliary instrument.

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7.1.2

Connecting / disconnecting fiber light cable Depending on the indication and field of use the operating area can be illuminated with the following: -- an esophagoscope telescope (1) -- the proximal lighting insert (3) -- or through the integrated cold--light connector (2.5) on the esophagoscope tube model “Wolf”. Plug the fiber light cable (A) onto the cold light connector (3.1 ) (fig. 3) and connect the other end to a suitable light source. Removal Press button (c) and remove fiber light cable (A) (fig. 3).

c 3.1

A fig. 3 Illustration by example of lighting insert (3).

7.1.3

Connecting the double blower The esophagus can be dilated with the tube closed by means of double blower (B). Esophagoscope tube model “WOLF”: Remove luer closure cap (2.3) and connect double blower (B) to luer fitting (2.2). 45

2.2

B 2.3

fig. 4

Esophagoscope tube for children

2.6

Connect double blower (B) to stopcock (2.6).

B

fig. 5

7

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7.1.4

Attaching the handle Slacken off the locking screw (8.1). Insert the connecting piece (2.4) into the handle (8) as far as it will go. Tighten the locking screw (8.1) as indicated by the arrow. The connection is secured.

2.4 8.1

8 fig. 6 7.2

Additional notes and instructions for use

7.2.1

Light IMPORTANT ! Use only products with type BF or CF applied parts in conjunction with this esophagoscope . 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 due to soiling/contamination in the light exit area if high- performance projectors 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 esophagoscope in a safe place. Switch off the light source if the esophagoscope 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.

7.2.2

Current WARNING ! Danger of electrical shock ! Patient leakage currents can add up if endoscopes are combined with electrically powered endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents.

7.2.3

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 esophagoscope before use.

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7.3

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 HF instrument is not visible through the scope ! Inadvertent tissue damage as well as damage to the distal end of the esophagoscope and the 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 high- frequency part is fully visible through the esophagoscope and in contact with the area to be treated.

x

WARNING ! HF arcing ! Danger of injury deu to incorrect HF application and insufficient distance between the HF instruments and other conductive parts. 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 esophagoscope tube (2) (fig. 7) when they are activated.

fig. 7 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.

7.4

Laser application 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 field of view of the scope ! Inadvertent tissue damage as well as damage to the distal end of the esophagoscope and to instrument parts are possible ! Activate the laser only if the tip of the laser fiber is fully visible through the esophagoscope and the pilot beam contacts the planned area to be treated. 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 ! There is the risk of eye injuries when working without filter attachment ! Use a suitable filter attachment on the eyepiece of the scope.

9

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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.

8.1

Visual check Check instruments and accessories for: damage sharp edges loose or missing parts rough surfaces. Replace damaged or brittle sealing caps (7.1/9.1) (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.

fig. 8

8.2

Functional check Check the individual components for compatitbility. Check the individual connections for secure connection. Check that the lighting insert has snapped in place. Check the illumination quality, remove any soiling on the light entry and exit surfaces.

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9

Reprocessing and maintenance IMPORTANT! For the reprocessing is described in the Manual GA--J020 “Reprocessing of RICHARD WOLF Thermally Stable Instruments“ and these instructions must be followed.

9.1

Disassembly before cleaning Remove auxiliary instruments. Remove sealing cap (7.1/9.1) Remove luer lock cap (2.3). Remove O--ring (4.1).

9.2

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning: see section 9.1 Manual cleaning / disinfection

9.3

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning: see section 9.1 Machine cleaning / disinfection

9.4

Checks Perform a visual check: sections 8 and 8.1.

9.5

Assembly before sterilization Attach O--ring (4.1) IMPORTANT! Do not screw on the luer cap before sterilization to allow a sufficient flow of the sterilization medium. Screw on the luer cap (2.3) before use.

9.6

Sterilization

9.6.1

Steam sterilization Steam sterilization at 134°C (273°F) using the fractional pre--vacuum method.

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Technical data and order data For this see the brochure entitled “Overview of permissible combinations” , order no.: BB--G 133

11

Spare parts and accessories For this see the brochure entitled “Overview of permissible combinations” , order no.: BB--G 133 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.

12.1

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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