Dilatation Instruments Instructions manual

Important general instructions for use Ensure that this product is only used as intended and described in the instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Operate this product only in the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and wearing 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 unit to be used or sold, except under the supervision of a medical doctor.

Safety instructions and levels of danger Symbol

Level of danger WARNING! Failure to observe can result in death or severe 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 D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (..49)--(0)7043--35--0 Fax:(..49)--(0)7043--35300 MANUFACTURER

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: (001)--847--913 1113 Fax: (001)--847--913 1489

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: (..44)--(0)208--944--7447 Fax: (..44)--(0)208--944--1311

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tél.: (..32)--(0)9--2808100 Fax: (..32)--(0)9--2829216

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tél.: (..33)--(0)3--26--870289 Fax: (..33)--(0)3--26--876033

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Lederergasse 32 A--1082 Wien Tel.: (..43)--(0222)1--405 6219 Fax: (..43)--(0222)1--408 7084

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GA--B 191

Contents 1

Intended use...

1

2

Indications and field of application...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

2 2

6 6.1 6.2 6.2.1 6.2.2 6.3 6.3.1 6.3.2 6.3.3

Use... Preparation... Examples of use and procedure... Guide rod, telescopic (2)... Guide rod, rigid (1)... Assembly... Guide rod, telescopic (2)... Guide rod, rigid (1)... Dilatation sleeve assembly (3)...

3 3 3 3 6 6 6 7 7

7 7.1 7.2

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

8 8 8

8 8.1 8.2 8.3 8.4 8.5

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

9 9 11 11 11 11

9

Technical data and order data... 12

10

Spare parts and accessories... 12

11

Operating, storage, transport and shipping conditions... 12

12

Disposal of product, packaging material and accessories... 12

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1

Intended use Instruments for dilatation are used to enlarge surgically created passages in body cavities. Guide rod, rigid Serves as a positioner to keep open an existing surgically created passage in order to exchange trocar sleeves. The guide rod is also used for palpation, retraction and dissection. Guide rod, telescopic This guide rod, which in the beginning is used like a rigid rod, is unlocked when the dilatation sleeve assembly or suitable trocar sleeve is passed over it and is pushed together telescopically when pressure is applied to the distal inner part of the rod. This will reduce the pressure on the deeper organs and tissue layers. The groove on the inner part of the rod serves to guide the scalpel for a controlled extension of the incision and at the same time prevent inadvertent slipping. Dilatation sleeve, complete Serves to bridge the difference in diameter from a smaller trocar sleeve to a larger trocar sleeve.

2

Indications and field of application For examination, diagnosis and/or therapy in the various medical disciplines such as. surgery, urology, gynaecology in connection with endoscopic accessories. These instruments must only be used by adequately 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 The instruments for dilatation are used in connection with trocar sleeves, instrument sleeves and extraction sleeves as well as endoscopic accessories. CAUTION! When different products are combined they must be compatible in their intended uses and relevant technical data (working length, diameter, etc.). For a general overview please refer to the current catalog sheets. Follow the instruction manuals of the products used in combination with this product. In addition to this manual the following manual must be observed: RIWO ART Trocar Sleeves Order no.: GA- B 129

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Illustration

Fig. 1

1

2

c

2.1

2.5

b

2.2

#

a

2.4

3.1

3

5.1

2.3

Legend and identification Item

Designation

Item

1

Guide rod, rigid

3

Dilatation sleeve

2

Guide rod, telescopic

3.1

Sealing cap

2.1

Inner part of rod

a

Openings

2.2

Ball catch

b

Locking bore (for ball catch)

2.3

Grip, movable

c

Guide groove for scalpel

2.4

Tongues

#

Identification no.

2.5

Outer tube of rod

<60

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Designation

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).

2

6

Use

6.1

Preparation Check assembly (see chapter 6.3) Run through the checks (see chapter 7)

6.2

Examples of use and procedure

6.2.1

Guide rod, telescopic (2) The dilatation procedure is described by example of the RIWO ART trocar sleeves from dia. 10 mm to dia. 12.5 mm.

Fig. 2

Fig. 3

2 A Body cavity Skin

Organ Remove endoscope (A) or auxiliary instrument from trocar sleeve dia. 10 mm.

3

Insert guide rod (2) in dia. 10 mm trocar sleeve. (In its extended position guide rod (2) is locked and cannot be pushed together like a telescope).

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Fig. 4

Fig. 5

3

Remove dia. 10 mm, trocar sleeve.

Insert dilatation sleeve assembly (3) into larger trocar sleeve dia. 12.5 mm.

Fig. 6

Fig. 7 2.3

3

2

3 2

Push dilatation sleeve assembly (3), together with larger trocar sleeves dia. 12.5 mm, over guide rod (2).

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Angle grip (2.3) on guide rod (2). (The locking mechanism is unlocked by the dilatation sleeve assembly (3), guide rod (2) can be pushed together telescopically).

4

Fig. 8

Fig. 9

3 2

B c

Insert scalpel (B) in groove (c) and extend incision.

Introduce the dia. 12.5 mm trocar sleeve equipped with dilatation sleeve (3) under gentle pressure in a rotational movement into the abdomen. Guide rod (2) is pushed together telescopically.

CAUTION! Observe and check the dilatation procedure, in particular the position of the distal end of the guide rod, intraabdominally through the scope.

Fig. 10

Fig. 11 2 3

Remove dilatation sleeve assembly(3) together with guide rod (2).

5

The dia. 12.5 mm trocar sleeve is in the abdomen. The dilatation procedure is completed.

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6.2.2

Guide rod, rigid (1) CAUTION! Danger of injury for deeper- seated organs and layers of tissue! Deeper- seated organs and layers of tissue could be injured when the larger trocar sleeve penetrates into the abdomen with the help of the dilatation sleeve assembly. Do not exert any axial force onto the rigid guide rod as the larger trocar sleeve assembly penetrates into the abdomen with the help of the dilatation sleeve. The use with rigid guide rod (1) corresponds to the procedure under 6.2.1. Neither angling the grip (Fig. 7) nor the telescopic procedure (Fig. 9) are possible and can therefore be omitted.

6.3

Assembly

6.3.1

Guide rod, telescopic (2) Insert the inner part of the rod (2.1) in the outer tube of the rod (2.5) up to the stop at the ball catch (2.2) (Fig. 12).

Fig. 12

2.1

2.5

2.2

Keep ball catch (2.2) depressed and insert the inner part of the rod completly (Fig. 13).

Fig. 13

2.2 2.1

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6

Insert movable grip (2.3) in outer tube of rod (2.5) as far as it will go and turn as indicated by the arrows (Fig. 14). The movable grip (2.3) engages.

Fig. 14

2.5

2.3

Pull out inner part of rod (2.1) and turn until the ball catch engages (Fig.15).

Fig. 15 2.1

2.2

6.3.2

Guide rod, rigid (1) not required

6.3.3

Dilatation sleeve assembly (3) Put on seeling cap (3.1) (Fig. 16)

Fig. 16

3

7

3.1

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7

Checks IMPORTANT! Run through the checks before and after every use. IMPORTANT! Do not use the products if they are damaged, incomplete or have loose parts. Send in damaged products together with loose parts for repair. Do not attempt to do any repairs yourself.

7.1

Visual check Check the instruments, in particular the distal parts, for damage, sharp edges and rough surfaces. Check sealing cap for damage and cracks. Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identifications which may lead to wrong handling or reprocessing must be replaced.

7.2

Functional check Guide rod, telescopic (2) Check snap--in function of ball catch (2.2) and grip (2.3) in outer tube of rod (2.5). Check easy movement of grip (2.3). Insert dilatation sleeve assembly (3) into extended guide rod (2) until the ball catch (2.2) is no longer visible. Check the guide rod (2) under slight pressure for easy telescopic action when pushed together.

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8

Reprocessing and maintenance NOTE! Follow the ”Instructions on the reprocessing of R.Wolf products, accessories and devices”, order no.: GA--J 020, where the following procedures are described in detail.

8.1

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning Guide rod, telescopic (2) Push together the grip tongues (2.4) through openings (a) of the outer tube (2.5) of the rod while removing grip (2.3) (Fig. 17).

Fig. 17 2.4

a 2.3

2.5

Push the inner part (2.1) of the rod at the distal end as indicated by the arrow and remove it from the outer tube of the rod (2.5) at the proximal end. (Fig. 18).

Fig. 18

2.1

2.5

Dilatation sleeve assembly (3) Remove sealing cap (3.1), (Fig. 19).

Fig. 19

3

9

3.1

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Manual cleaning / disinfection Guide rod, telescopic (2) Rinse outer tube (2.5) with a cleaning gun and a suitable cleaning brush, (Fig. 20).

Fig. 20

2.5

Clean inner part (2.1) of rod and guide groove (c) with a cleaning cloth or brush (Fig. 21).

Fig. 21

c

2.1

Clean grip (2.3) in straight position using the necessary cleaning brushes (Fig. 22).

Fig. 22 2.3

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Clean the movable part of grip (2.3) so that no contaminants/dirt particles remain in the joint (Fig. 23).

Fig. 23 2.3

Guide rod, rigid (1) Clean rigid guide rod (1) with a cleaning cloth or brush (Fig. 24).

Fig. 24

1

8.2

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning Same procedure as described under ”manual reprocessing” Machine cleaning / disinfection Clean grip (2.3) manually (see Fig. 23).

8.3

Checks see chapter 7

8.4

Assembly before sterilization see chapter 6.3

8.5

Sterilization Steam sterilization at 134°C (272°F) using the fractional method. Connect and adapt all parts to the washer trolley in such a way that all surfaces can be reached by the reprocessing medium.

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Technical data and order data Guide rod

Extension of incision [mm]

Trocar sleeve slant. RIWO ART

Instrument sleeve

SZ 5 mm WL 155 mm

CAP 5,5 mm WL 100 mm

8923.921

8923.931

5,5mm TL 500 mm

8923.013

SZ 10 mm WL 170 mm

8385.50

(8934.951

CAP 10 mm WL 100 mm

(8934.95)

10 mm WL 170 mm

5 mm TL 500 mm)

SZ 10 mm WL 172mm

8941.901

8924.013 10 < 12,5

10 < 15

Guide rod rigid

8941.951 12 mm WL 180 mm

Extraction sheath for laparoscopy

telescopic

8943.901

8943.902

10mm TL 500mm

10mm TL 500mm

8945.982

10 < 20

10

12 mm WL 180 mm

CAP 12,5 mm WL 100 mm

Extension of incision [mm]

Reduction sleeve

8383.78

8921.013

3,5 < 5,5

5,5 < 10 (5,0 < 10)

Dilatation sleeve

Ø 20 mm

Spare parts and accessories Illustration

Model/type Designation, technical data no. (Length / diameter in [mm], PU = packaging unit) 6.12

CLEANING BRUSH Ø 12MM TL 700MM

6.20

CLEANING BRUSH Ø 20MM TL 620MM

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 GmbH or your R. 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

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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