Optical Forceps 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.

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IMPORTANT! Failure to observe can result in damage to the product or surroundings.

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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 info@richard- wolf.com 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]

info@richard- wolf.at www.richard- wolf.at

endoscopy@richard- wolf.be 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 middle.east@richard- wolf.com 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 india@richard- wolf.com 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... Legend and identification...

3 3

7 7.1 7.1.1 7.1.2 7.1.3

4 4 4 4

7.2 7.2.1 7.2.2

Use... Preparation... Inserting telescope (2) in optical forceps (1)... Connecting the telescope (2) to the system components... Inserting optical forceps (1) in bronchoscope / removing optical forceps (1) from bronchoscope... Additional notes and instructions for use... Light... Current...

8 8.1 8.2 8.2.1

Checks... Visual check... Functional check... Telescope (2)...

7 7 7 8

9 9.1 9.2 9.3 9.4 9.5 9.6 9.6.1 9.6.2

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steam sterilization... STERIS und STERRAD sterilization procedures...

9 9 9 9 9 10 10 10 10

10

Technical data and order data... 11

11

Spare parts and accessories... 11

12 12.1

Operating, storage and transport and shipping conditions... 11 Disposal of product, packaging material and accessories... 11

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5 6 6 6

I

1

Technical Description Optical forceps consist of: ' Telescope guide tube ' Receptacle with conical housing and locking ring for connecting telescopes ' Handle ' Double- action forceps jaws, controllable by thumb via the movable grip section.

2

Intended use Optical forceps are used for endoscopically controlled ' grasping, manipulating and dissecting of tissue ' Removal of foreign bodies ' Removal of tissue parts that have already been severed. ' Placement and withdrawal of stents The instrument is introduced into the operating area via natural and surgically created passages.

3

Indications and field of use For examination, diagnosis and/or therapy in conjunction with endoscopic accessories in the medical disciplines of Z ENT ' Nose ' Pharynx, Larynx ' Bronchoscopy ' Oesophagoscopy Z SURGERY ' Thoracoscopy

4

Contraindications CJD - Creutzfeldt- Jakob Disease or vCJD - Variant of the Creutzfeldt- Jakob Disease BSE - Bovine Spongiform Encephalopathy; the so- called mad cow disease (e.g. Creutzfeldt- Jakob disease) TSE - Transmissible spongiform Encephalopathy On the basis of the patient’s general condition the physician / surgeon in charge must decide whether the planned use is possible or not. Follow the regulations and laws valid in your country. For further information see the latest medical literature. Contraindications directly related to the product are presently unknown.

5

Combinations Optical forceps are used in conjunction with: Z Telescopes Z Endoscopic accessories such as: ' Bronchoscopes ' Tracheoscopes 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. Make sure you observe the instructions of the brochure entitled ”Overview of permissible combinations”, order no.: BB- G 119.

1

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Fig. 1 2.1

Z The cold- light connector (2.1) can be unscrewed and replaced by suitable adaptors to connect fiber light cables of other manufacturers. For the order number please refer to the latest catalog sheet.

Fig. 1

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2

6

Illustration 1.1

1

1.3 1.4

1.2

#

1.5

#

2.1

2 Fig. 2 6.1

#

Legend and identification Item

Item

Designation

1

Designation Optical forceps

2

Telescope

1.1

Jaws

2.1

Cold- light connector

1.2

Telescope guide tube

1.3

Locking lever

#

Product no.

1.4

Locking mechanism

1.5

Forceps handle

Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Serial 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).

3

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7

Use CAUTION ! The products have only limited strength ! Exerting excessive force will cause damage, impair the function and therefore endanger the patient. Avoid torsional forces. 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 Z Perform a check: sections 8 and 8.1 Z Fasten the cold- light connector (2.1).

7.1.1

Inserting telescope (2) in optical forceps (1) Fig. 3

1.3

I

IIa

b

I

II a b

1

2

Locking: L The locking lever (1.3) is in position “ I” . Z Insert telescope (2) in optical forceps (1). ' Pin (a) engages in groove (b). Z Turn the locking lever (1.3) to position “II” . ' Both components are locked together. Unlocking: L The locking lever (1.3) is in position “ II” . Z Turn the locking lever (1.3) to position “I”. ' The locking mechanism is unlocked. Z Remove the telescope (2) from the optical forceps (1).

Fig. 3

7.1.2

Connecting the telescope (2) to the system components Fig. 4 Z Connect the fiber light cable via the cold- light connector to a suitable light source. Z Connect the telescope (2) to the a camera and camera controller.

. NOTE !

To obtain optimum light transmission, the diameters of the fiber core of the telescope (2) and of the fiber light cable must be the same. Possible causes when using a fiber light cable that

2 Fig. 4

' is too large: the coupling point with the telescope (2) may become excessively hot ' is too small: the light output is reduced For a suitable fiber bundle diameter please check the product number of the fiber light cable. ' the code number on the cold- light connector (2.1) must correspond with the two digits to the right of the decimal point of the product number The fiber light cable 8061.933 has a fiber bundle Exception: diameter of 3.5 mm. Recommended: Fiber bundle diameter of the telescope fiber light cable: 8462.30 and 8464.30 = 1.6 mm (8061.16 / 8061.163) 8465.30 = 2.5 mm (8061.253)

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4

CAUTION ! Intense heat due to high light energy ! In the case of unfavorable combinations, using the highly temperatureresistant fiber light cable 8063.353 can cause a temperature increase at the coupling point between the fiber light cable and the telescope (2). The user may get burns and the telescope can become damaged. Reduce the light output, if necessary use fiber light cable with product no. 8061.xxx / 8062.xxx. Z Perform a functional check: section 8.2 7.1.3

Inserting optical forceps (1) in bronchoscope / removing optical forceps (1) from bronchoscope CAUTION ! Danger of injury when inserting the optical forceps (1) if the forceps is not in the surgeon’s field of view ! Inadvertent tissue damage is possible. Insert the optical forceps (1) only under visual control. Carry out the manipulations only if the optical forceps (1) is fully visible through the scope. CAUTION ! Danger of injury when inserting and removing the optical forceps (1) with open jaws ! This may cause inadvertent tissue damage, damage to the distal end of the bronchoscope / tracheoscope tube as well a loss of particles from the jaw section. Insert the optical forceps (1) into the tube or withdraw it from the latter only with the jaw section closed and under visual control. Fig. 5

A

B

1

2

CAUTION ! Danger of injury ! For bronchoscope models 8210.405/ .505/ .605/ .655/ .705/ .805 observe the following: To prevent injuries of the patient as well as damage to the optical forceps (1) during insertion or withdrawal, insert or remove the forceps (1) at an angle of 90_ relative to the cold- light connector (B) of bronchoscope (A).

Fig. 5

Z Close the jaws of the optical forceps (1) and insert in bronchoscope together with suitable telecope (2).

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7.2

Additional notes and instructions for use

7.2.1

Light

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IMPORTANT ! Use only products with type BF or CF applied parts in conjunction with the telecope. 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 source 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 telescope (2) in a safe place. Switch off the light source if the telescope (2) 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 telescopes (2) are combined with electrically powered endoscopic accessories. Make sure that the combinations do not exceed the permissible patient leakage currents.

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6

8

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 Z Check instruments, in particular in the distal area, and accessories for ' damage ' sharp edges not in conformity with the application ' loose or missing parts and ' rough surfaces. Z 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.

1.1

C

Fig. 6 Z Check the teeth on the jaws for damage. ' If the teeth on the jaws are damaged, do not use the grasping forceps (1). Z Check the jaws (1.1) for defective cutting edges. ' The cutting edges of the jaws (1.1) must be sharp. CAUTION ! Caution if surface in the hinge area of the forceps is damaged ! The hinge pin (C) can loosen. Check for surface changes, such as hairline cracks, around the hinge pin (C).

1.1 Fig. 6

C Z With the telescope (2) in place, the jaw section (1.1) must be in the user’s field of view.

8.2

Functional check Z Check the various products for compatibility. Z Check that the various connections are securely connected. Z Check for easy assembly and easy operation of the locking mechanism on the individual instruments. Replace the instruments if the connection, ' is not safe although it is locked, ' cannot be locked or is difficult to lock. Z Check for easy insertion / removal of ' telescope (2) in / from optical forceps (1) ' optical forceps (1) in / from bronchoscope Z Check that the jaws (1.1) open and close easily.

7

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8.2.1

Telescope (2) Z Check image quality and illumination power using system components. Z Check the glass surfaces for deposits ' 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 in alcohol (wooden swab carrier, not metal or plastic), remove hard- to- remove deposits with instrument cleaner* (Fig. 7). *see Manual GA- J020 ”Reprocessing of RICHARD WOLF Thermally Stable Instruments”.

Fig. 7

Z Check the illumination power (light output) without system components. Z Hold the distal end of the telescope towards a light source. ' Broken fibers appear as black dots in the cold- - light connector. If approx. 30% of the fibers are broken, the light output is no longer sufficient (Fig. 8).

Fig. 8

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8

9

Reprocessing and maintenance WARNING ! Creutzfeldt- Jakob Disease ! If the patient is suspected of having the Creutzfeldt- Jakob Disease (CJD) or a variant of the Creutzfeldt- Jakob Disease (vCJD) or such a disease has been diagnosed, adequate measures must be taken to prevent a possible transmission to other patients, users and third parties. For this purpose, apply the country- specific reprocessing regulations and guidelines.

.

9.1

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

Disassembly before cleaning Z Remove all connections between the telescope (2) and the system components. Z Remove the optical forceps (1) from the bronchoscope. Z Remove the cold- light connector (2.1).

9.2

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

9.3

Machine reprocessing Z Dry preparation at the point of use Z Disassembly before cleaning: section 9.1 Z Machine cleaning / disinfection ' To guarantee proper machine reprocessing, place the optical forceps (1) with open jaws into the washer / disinfector. For this, we recommend using the cleaning clamps (D). Fig. 9 Z Secure the handle (1.5) with the cleaning clamp (D) as shown.

D

Fig. 9

1.5

Z After machine reprocessing, remove the cleaning clamp (D).

9.4

Checks Z Perform a visual check: section 8 and 8.1

9

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9.5

Assembly before sterilization

.

NOTE ! Before sterilization screw on screw connections only loosely to allow adequate flow of the sterilization medium. Tighten all screw connections before use. Z Screw on the cold- light connector (2.1) loosley only 1- 2 turns. Fig. 10 Z Sparingly oil all movable parts with instrument oil. ' Actuate the handle (1.5) several times. Z Remove any excess oil.

1.5 Fig. 10

9.6

Sterilization

9.6.1

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

9.6.2

STERIS und STERRAD sterilization procedures

.

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NOTE ! The STERIS  and STERRAD  sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility.

10

10

Technical data and order data For this, see the brochure entitled “Overview of permissible combinations for optical forceps”, order no.: BB- G 119.

11

Spare parts and accessories Item

Illustration

Product no.

Designation, technical data

D

103.01

CLEANING CLAMP SHORT Clamping range up to 75 mm Packaging unit = 10 / pkg.

D

103.02

CLEANING CLAMP LONG Clamping range 75 - 110 mm, Packaging unit = 10 / pkg.

6.041

CLEANING BRUSH Ø 3MM TL 365MM

6.045

CLEANING BRUSH Ø 2MM TL 240MM

6.05

CLEANING BRUSH Ø 5MM TL 515MM

-

6.12

CLEANING BRUSH Ø 12MM TL 700MM

-

86.90

CLEANING BRUSH

-

200.532

INSTRUMENT OIL (27.5 ml)

-

BL

-

D

TL

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 representative.

12

Operating, storage and 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

. 12.1

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

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.

11

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