Shoulder Suture Set Sterilization Basket Instructions Manual

Important general notes and instructions for use Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, and that maintenance and repair is only carried out by authorized specialized technicians. 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 application and if the performance characteristics and safety requirements are met. Reprocess the products before every application and before returning them for repairs 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.

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

GA-J 045

Contents 1

Technical description...

1

2

Intended use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1 5.2 5.3 5.4 5.4.1 5.5

Use... Preparation... Opening/Closing sterilization basket... Changing the latch (A)... Loading the sterilization basket... Labeling with spring action for sterilization basket... Changing silicone holders...

2 2 2 3 4 7 7

6

Checks...

8

7 7.1 7.1.1 7.2

Reprocessing and maintenance... 9 Sterilization... 9 Packing... 9 Re-usable snap-on plate for system basket... 10

8

Technical data and order data... 11

9 9.1

Spare parts and accessories... 11 Service life... 11

10 10.1

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

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1

Technical description

The sterilization basket for the Shoulder Suture Set consists of: Sieve basket bottom section. Sieve basket lid. Instrument carrier top and bottom. Special mounting units and silicone holders. Locking mechanism.

2

Intended use

3

Contraindications

4

Combinations

The sterilization basket is intended for accommodating the medical instrument set during sterilization and storage.

When the product is being used, there are no specific medical contraindications.

IMPORTANT ! In addition to this manual, follow the instruction manuals of the instruments and the sterilizers that are used in combination with these products.

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5

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.

5.1

Preparation

5.2

Opening/Closing sterilization basket

Carry out a check: see section 6 Opening (Fig. 1): Place the sterilization basket on a flat surface and unlock all latches (A). Lift sieve lid (1) upward.

1

A

Fig. 1 Closing (Fig. 2):

1

Place the sieve lid (1) on the sieve bottom section (2) and fasten all latches (A).

A Fig. 2

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2

2

5.3

Changing the latch (A)

A

Dismantling the latch: Turn the latch (A) to the side until the latch lug (B) is pushed out of the latch bracket, then pull downward.

B

Fig. 3

A Inserting the latch: B

Push the latch lug (B) into the latch bracket from below and make the latch (A) engage by pulling in the direction of the arrow.

Fig. 4

3

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5.4

Loading the sterilization basket IMPORTANT ! The loaded sterilization basket must not be turned over (placed the wrong way up) during packing, transport and storage, because otherwise the instruments may become dislodged from the silicone holders. Place the instruments in accordance with the labeling on the floor of the instru­ ment carrier (see figure 6 and 8) in the silicone mounts. The sterilization basket should be loaded with max. 8.5 kg. Make sure you follow the instruction manual for the relevant products.

Load instrument carrier, top (Fig. 5)

Fig. 5 Labeling of instrument carrier, top:

Fig. 6

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4

Load instrument carrier, bottom (Fig. 7)

Fig. 7 Labeling of instrument carrier, bottom:

Fig. 8

5

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Place instrument carrier, bottom in sieve basket bottom section (Fig. 9)

Fig. 9 Place instrument carrier, top in sieve basket bottom section (Fig. 10)

Fig. 10 Close sieve basket bottom section with sieve basket lid (Fig. 11) see also section 5.2

Fig. 11

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6

5.4.1

Labeling with spring action for sterilization basket

Fig. 12 5.5

Changing silicone holders Remove damaged silicone holder (C) from the mounting unit (D). Push on the silicone holder (C) until it snaps onto the bolt (x) of the mounting unit (D).

D

C Fig. 13

X NOTE ! Side notches indicate the position of the individual silicone holders in the mount­ ing unit to help with placement.

Fig. 14

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6

Checks CAUTION ! Be careful if products are damaged or incomplete ! Injury may be caused to the user and third parties. 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 carry out any repairs yourself. Check the sterilization basket for damage, loose and missing parts. Check silicone holders for damage. Replace any damaged silicone holders (see spare parts). Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identification leading to wrong hand­ ling and reprocessing must be reinstated.

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7

Reprocessing and maintenance IMPORTANT ! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-Stable Instruments", and these must be followed.

7.1

Sterilization IMPORTANT ! Before sterilization is carried out, all screw connections on the instrument should only be tightened loosely, so that: adequate sterilization medium can flow in and to prevent stress cracks. Tighten all screw connections before use. IMPORTANT ! The maximum permissible loading of the sterilizer must be adhered to.

Carry out sterilization in accordance with the instrument set used and the en­ doscopic accessories. Make sure you follow the instruction manuals for the relevant products. For purposes of sterilization, pack the sterilization basket in a sterile packing (soft) (Fig. 15) or use an appropriate sterile container (Fig. 16), in accordance with the specific national standards.

7.1.1

Packing

Soft

Fig. 15

Sterile container

Fig. 16

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7.2

Re-usable snap-on plate for system basket

Fig. 17

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8

Technical data and order data

9

Length

Width

Height

Weight

530 mm

250 mm

108 mm

4.67 kg

Spare parts and accessories Product no.

Designation, technical data

8584.5202

BASKET LOWER W 250MM L 530MM H 101MM

8584.6201

BASKET LID

8584.2002

CAP SHORT

74018097

Instrument carrier, top

74018104

Mounting unit

85849101

SILICONE HOLDER SET UPPER SHOULDER

74018098

Instrument carrier, bottom

74018105

Mounting unit

85849102

SILICONE HOLDER SET LOWER SHOULDER

Further accessories on request

9.1

Service life

10

Operating, storage, transport and shipping conditions

The sterilization basket can be used, provided no damage is identified, see checks (section 6).

Operating conditions

Sterilization in accordance with the instruments used in the sterilization basket and the endoscopic accessories

Storage conditions

In accordance with the instruments used in the sterilization basket and the endoscopic accessories

Transport and shipping conditions, empty instrument sieve

--20°C to +60°C, 10% to 90% rel. humidity, air pressure 700 hPa to 1060 hPa

Reprocessing conditions, empty sterilization basket

Machine--cleaning / Disinfection Steam sterilization with a fractional prevacuum process at 134°C (273°F) Gas sterilization (EtO)

IMPORTANT ! The sterilization baskets must not be used for shipping instruments and endoscopic accessories.

10.1

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

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