Biopsy forceps Tip Control Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, Maintenance and repair must be 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 appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

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 !

User tips for optimum device use and other useful information.

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GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [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 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-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 A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

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

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 4.1 4.2

Contraindications and side effects... Contraindications... Side effects...

1 1 1

5

Combinations...

1

6 6.1 6.2

Illustration... Legend and identification... Symbol...

2 2 2

7 7.1 7.2 7.2.1 7.2.2 7.2.3

Use... Preparation... Additional notes and instructions for use... Locking / unlocking the forceps handle... Deflecting the jaw section... Selecting the position of the jaw section...

3 3 3 3 4 4

8 8.1 8.2

Checks... Visual check... Function check...

5 5 5

9 9.1

Reprocessing and maintenance... Reprocessing procedure...

6 6

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:

2

Intended use

Jaw section deflectable by means of proximal control lever one movable jaw, controlled by actuating the forceps handle. Sheath tube with 2 proximal rinsing connectors for cleaning rotatable through 360° relative to the forceps handle and lockable in any po­ sition. Forceps handle With locking lever for locking the jaw section in the closed position. TipControl biopsy forceps Is used for grasping and removing tissue and taking tissue samples as well as for removing foreign bodies and for ablating tissue and gaining histological tissue. TipControl grasping forceps Is used for grasping , repositioning and removing endobronchial stents or foreign bodies. TipControl scissors are used for cutting endobronchial stents. These products are exclusively intended for use by specialized medical personnel and may only be applied by adequately qualified and trained medical doctors.

3

Indications and field of use

4

Contraindications and side effects

4.1

Contraindications.

The product is used for the examination, diagnosis and / or therapy in conjunction with endoscopic accessories in the tracheobronchial space and oesophagus.

CJD - Creutzfeldt Jakob Disease or a vCJD - Variant of the Creutzfeldt-Jakob Disease BSE - Bovine Spongiform Encephalopathy; so-called mad cow disease (e.g. Creutzfeldt-Jakob Disease) TSE - Transmissible Spongiform Encephalopathy On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. Comply with the laws and regulations valid in your country. For further notes and instructions please refer to the latest medical literature. Contraindications directly related to the product are presently unknown.

4.2

Side effects

5

Combinations

No side effects are to be expected if the system is used as intended. The TipControl forceps / and scissor instruments are mainly used in conjunction with Richard Wolf Texas tracheo-bronchoscopes.

CAUTION! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possi­ ble. 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 combination with this prod­ uct.

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6

Illustration 2 0001

1

11

12

10 9

7

XXXXXXXxxx

0002

3

6

3

1

8 11 0003

4

1

12

5

5a

Fig. 1 6.1

6.2

Legend and identification Item

Designation

Item

Designation

1

Jaw section

7

Control lever

2

Outer tube

8

Clamping screw

3

Luer connector (for cleaning)

9

Clamping sleeve

4

Luer sealing cap

10

Angle lever

5

Handle

11

Lot no.

5a

Movable handle section

12

Identification no.

6

Lock

Symbol Symbol

Designation Observe the instruction manual

REF

Order number

LOT

Lot identification number

SN

Serial no. Identification in conformity with Medical Product Directive 93/42/EEC, only valid if the product and/or the packaging is marked 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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2

7

Use CAUTION! The products have only limited strength! 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. Do not use the products if they are damaged or incomplete or have loose parts.

7.1

Preparation

7.2

Additional notes and instructions for use

Check assembly: see page 9 “Assembly before sterilisation“ Carry out a check: see sections 8 and 8.1

IMPORTANT! Make sure that the forceps / scissors are closed when you insert them in or re­ tract them from the patient's body. 7.2.1

Locking / unlocking the forceps handle Fig. 2 Locking: Compress the movable handle section (5a) and turn the lock (6) in direction of arrow as far as it will go. The jaw section (1) is closed and locked.

1

6

5a

Fig. 2 Unlocking: Turn the lock (6) in the opposite direction of the arrow as far as it will go. The jaw section (1) is open.

3

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7.2.2

Deflecting the jaw section Fig. 3 Actuate the control lever (7).(Fig. 3) The jaw section (1) is deflected.

1

7

Fig. 3 7.2.3

Selecting the position of the jaw section Fig. 4

NOTE! The jaw section (1) can be rotated through 360° and locked in a position favorable for the surgeon. Turn the clamping screw (8) in direction of the arrow marked „open“ . Turn the jaw section (1) by the outer tube (2) to the required position. Turn the clamping screw (8) in direction of the arrow marked „open“ as far as it will go.. The jaw position is locked.

1 8

close

open

Fig. 4

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4

8

Checks CAUTION! Be careful if products are damaged or incomplete! Injuries of the patient, user and 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

Check the products and the accessories for: Damage Surface changes (e.g. corrosion, cracks in the jaw components and around the hinge) sharp edges not suitable for the application loose or missing parts rough surfaces. Any inscriptions or identification necessary for the safe intended use must be legi­ ble. To prevent wrong handling or reprocessing, any illegible lettering, labeling or identification must be reinstated. Check the jaw section (1) for damage. Do not use the forceps / scissors if the jaw section is damaged. The cutting edges of the scrissors must be sharp. CAUTION! Be careful if the surface around the forceps / scissor hinge is damaged! The joint pin may loosen. Check for surface changes such as hair cracks etc. around the hinge pin.

Fig. 5

8.2

Function check

5

Check for easy operation of the jaw section (1) when opening and closing the forceps handle. Check the jaw section (1) for easy rotation and deflection (1). See sections 7.2.2 and 7.2.3.

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9

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

9.1

Reprocessing procedure IMPORTANT! If used as intended and following the manufacturer's instruction manual, it is not necessary to limit the number of possible reprocessing cycles. Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products. Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle. The user must ensure that the reprocessing process including the resources, materials and personnel are suitable to achieve the required results. The national and international requirements regarding the validation of the user's reprocessing process must be followed. IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-stable Instruments" and must be followed. IMPORTANT! Do not sterilize the products in hot-air sterilizers.

Preparation at the point of use

Transport

Immediately after use, remove coarse soiling from the products. If there are more than 6 h between use and reprocessing, rinse out the hollow spaces and lumens with a 5 ml syringe filled with water. For this purpose unscrew the seal­ ing cap (4), see fig. 5. Do not use cleaning agents (e.g. aldehyde) or hot water (>40°C) for precleaning as these can bake residues to the surfaces. To avoid damage to the products and contamination of the environment, the products must be stored safely in a closed container. Unscrew the luer sealing cap (4).

3 3

Fig. 6 Precleaning:

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4

Immerse the instrument in cold water for 5 minutes, fill the lumens using a syringe. Move the scissor section and the grip deflection mechanism 5 times. Rinse out the outer tube via the luer connectors (3) by applying 5 pressure surges of 5 seconds each with a water gun (3 to 4 bar of static pressure). Rinse the instrument with cold water under the tap. Move the scissor section and the grip deflection mechanism 5 times.

6

Disassembling the instruments

Control lever (7) Push against the square (x) of the control lever (7) until it disengages from the square hole. Remove the control lever (7) in direction of arrow. 180°

X

7

Fig. 7

7

Outer tube (2): Open the clamping screw (8) as far as it will go. Disengage the ball (A) at the proximal end of the outer tube from the groove (B) on the handle. Pass the proximal end of the outer tube through the clamping sleeve (9) in the direction indicated by the arrow. The outer tube (2) can be removed.

2

A

5

9 8

Fig. 8

B

Then: Rinse out all lumens of the outer tube with 10 ml of 0.5% cleaning solution. Ultrasonic cleaning

Immerse the disassembled instruments in a 0.5% cleaning solution making sure that all lumens are completely filled. Exposure time: 5 min Temperature max.: 40°C Frequency: 35 kHz At the end, rinse the instruments with cold water under the tap.

7

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Manual cleaning

Immerse the disassembled instruments in a 0.5% cleaning solution for 5 min. Rinse out all lumens of the outer tube with 10 ml of 0.5% cleaning solution. Then brush the outer surfaces of the instruments with a suitable brush until all visible soiling has been removed. After brushing, rinse out the lumens of the outer tube (2) consecutively via the corresponding rinsing connectors with 5 pressure surges of 5 seconds each using a water gun (3 to 5 bar of static pressure). Rinse the instruments with cold water under the tap.

Fig. 9 Manual disinfection

Immerse the instrument in a certified disinfectant solution. For the exposure time follow the manufacturer's instructions. Fill the outer tube (2) via the luer connectors (3) with a disinfecting solution. Finally rinse out the outer tube (2) with water for at least 15 seconds using a cleaning gun. Rinse the instruments with water.

Manual drying

Dry the outer surfaces of the instruments with a lint-free disposable cloth or swab, dry the hollow spaces with filtered compressed air.

Machine cleaning

Before machine cleaning, preclean the instruments manually. Connect the luer connectors (3) to the washer-disininfector using rinsing hoses. Open the jaw section (1). Sequence of operations: 2 min. of precleaning with cold water under the tap. Empty 5 min. of precleaning with 55°C fully desalinated water and 0.5 % cleaning solution. Empty 3 min. of rinsing with cold fully desalinated water. Empty 2 min. of rinsing with cold fully desalinated water. Empty Thermal machine disinfection following the national requirementss regarding the AO value Dry the products in the drying cycle of the washer-disinfector. If necessary, additional drying is achieved manually using a lint-free disposable cloth or swab or, alternatively, in a drying cabinet. Dry hollow spaces with fil­ tered compressed air.

Function test Maintenance

GA-G 139

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

8

Assembly before sterilization

NOTE! Before sterilization, screw on the screw connections only loosely in order to allow a sufficient flow of the sterilization medium. to prevent stress cracks. Tighten all screw connections before use. IMPORTANT! Instruments with luer lock sealing caps ! Do not screw on or plug on luer sealing caps (4) before sterilization to allow a sufficient inflow of the sterilization medium. Screw on the luer sealing caps (4) before use.. Install the sheath tube (2) with handle (5).

NOTE! The handle (5) and the outer tube (2) are a matched pair and cannot be combined with other forceps, scissors or handles. For assembly the lot number (11) and identification number. (12) on the handle (5) and on the outer tube (2) must be the same. Pass the proximal end of the outer tube (2) through the clamping sleeve (9) and engage the ball (A) in the groove (B). Make sure that the narrowing (recess) (C) lies in the holder (D) on handle (5). Tighten the clamping screw (8) in direction of arrow. XXXXXXX xxx

11

2

9

12

C

8

5

A B

Fig. 10

9

D

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Control lever (7)

NOTE! The control lever (7) can be installed on the left or on the right. IMPORTANT! The control lever (7) will work only if it is installed in parallel with the outer tube. The sqare pin (x) of the control lever (7) and the square hole (y) on the angle lever (10) and in the handle (5) must be aligned. Push the sqare pin (x) of the control lever into the square hole (y) as shown in fig. 11 as far as it will go. The control lever (7) clicks into place..

10

X

5

y 7

Fig. 11 Sparingly oil all movable parts in the area of the jaw section, sheath and han­ dle. Remove any excess oil.

Fig. 12 Sterilization

Sterilize the products using the fractional pre-vacuum method (ISO17665) tak­ ing into account the national requirements. Temperature exposure time: 4 min at 134°C +4°C (273°F +7°F) 132°C +4°C (270°F +7°F) Evacuation:

3x

Drying time:

10 - 20 min

Maximum sterilization temperature: 138°C Positioning

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Store the sterilized products in a dry, clean and dust-free environment at temperatures between 5°C and 40°C.

10

Validation:

To validate reprocessing, the following materials and machines were used:

Manually: Cleaning agent: Cleaner 0.5% neodisher MediClean (Dr. Weigert) Machine: AWD:

Miele G7836CD

Rack:

Miele E 450/1

Program:

Vario-TD

Cleaning agent:

Cleaner 0.5% MediClean (Dr. Weigert)

Sterilization Sterilizer: Additional instructions

11

Selectomat HP 666-1 HRED (MMM)

In accordance with DIN EN ISO 17664 the user is obliged to validate the proce­ dure used.

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Technical data and order data Illustration

11

Product no.

Designation, Technical data

823400001

BIOPSY FORCEPS Ø 5.2MM 483MM

823400002

GRASPING FORCEPS Ø 5.2MM 485MM

823400003

SCISSORS Ø 5.2MM 482MM

Spare parts and accessories Illustration

Product no.

Designation, Technical data

15023205

Luer sealing cap

200.532

INSTRUMENT OIL

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

12

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.

12.1

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

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