Aspiration Ligature Instrument for Haemorrhoids 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 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.: 847--913 1113 Fax: 847--913 1488

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: 020--8944 7447 Fax: 020--8944 1311

E--mail: [email protected] Internet: www.richard--wolf.com

E--mail: sales&[email protected] Internet: www.richardwolfusa.com

E--mail: [email protected] Internet: www.richardwolf.uk.com

BELGIUM N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 B--9031 Gent --Drongen Tel.: +32 9.280.81.00 Fax: +32 9.282.92.16

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tel.: +33 3.26.87.02.89 Fax: +33 3.26.87.60.33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A--1160 Wien Tel.: +43 1-- 405 51 51 Fax: +43 1-- 405 51 51--45

E--mail: [email protected]

E--mail: [email protected]

E--mail: [email protected] Internet: www.richard--wolf.at

0

GA--F 048

Contents 1

Intended use...

1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1

Illustration... Legend and identification...

2 2

6 6.1 6.1.1 6.1.2 6.2

Use... Preparation... Attaching suction head (7) to aspiration ligature instrument for haemorrhoids (A)... Attaching the ligature ring (10) to the suction head, large (7)... Procedure...

4 4 4 4 5

7 7.1 7.2

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

5 5 5

8 8.1 8.2 8.3 8.4 8.5 8.5.1 8.5.2

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Sterilization... Steam sterilization... Sterilization processes Steris and Sterrad...

6 6 6 7 7 7 7 7

9

Technical data and order data...

8

10

Spare parts and accessories...

8

11 11.1

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

8 8

GA--F 048

I

1

Intended use The aspiration ligature instruments for haemorrhoids are used to ligature haemorrhoids and polyps using ligature rings. Suction head For holding the loading cone and for the aspiration of the haemorrhoids or polyp to be ligatured. Aspiration ligature instruments for haemorrhoids (A), removable suction head: Suction head (suction cup) “large” for the aspiration of large haemorrhoides / polyps Suction head (suction cup) “small ” for the aspiration of small haemorrhoids / polyps Loading cone Tool for sliding the ligature ring onto the suction head.

2

Indications and field of use For 2nd and 3rd--degree haemorrhoids / polyps in the area of the rectum in conjunction with endoscopic accessories. These instruments are used in the medical disciplines of proctoscopy and rectoscopy. NOTE ! The aspiration ligature instrument for haemorrhoids (B), (firmly attached suction head) 8324.00 is mainly used in conjunction with the operating rectoscope telescope 8830.401. The use in conjunction with proctoscope / rectoscope tubes is also possible.

3

Contraindications Contraindications directly related to the product are presently unknown. The physician/surgeon in charge must decide whether the planned use is possible or not on the basis of the patient’s general condition. For further information see the latest medical literature.

4

Combinations The aspiration ligature instrument for haemorrhoids is used in combination with: Proctoscope tubes [Aspiration ligature instruments for haemorrhoids (A) and (B)] Operating rectoscope telescope / rectoscope tubes [Aspiration ligature instruments for haemorrhoids(B)] Vacuum pump Endoscopic accessories CAUTION ! Caution 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 use and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product.

1

GA--F 048

5

Illustration

9

5

4

A 6 # #

#

14

1 10

8

7

12 11

3 2

13

B #

5.1

Legend and identification Item

Designation

Item

Designation

A

Aspiration ligature instrument for haemorrhoids

B

Aspiration ligature instrument for haemorrhoids

Removable suction head

Firmly attached suction head

1

Handle

11

Luer cap

2

Tube connector

12

Luer connector

3

Lever

13

Suction head, small

4

Pusher sleeve

14

Loading cone (countersunk)

5

Fork

6

Valve

#

Product no.

7

Suction head, large

8

Suction head, small

9

Loading cone (non--countersunk)

10

Ligature rings

GA--F 048

2

Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Series number Units, pieces Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging is marked with this symbol. Products in 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

GA--F 048

6

Use CAUTION ! The products only have 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. NOTE ! The colon can only be inflated if the aspiration ligature instrument for haemorrhoids (B) is used in conjunction with the operating rectoscope telescope 8830.401 and sealing adapter 8830.114

6.1

Preparation IMPORTANT! The ligature rings (10) are supplied non--sterile and must be reprocessed before use (see chapter 8). Carry out a check: section 7 and 7.1 The following describes the procedure by example of the disassemblable aspiration ligature instrument for haemorrhoids (A) with suction head, large (7). The procedure with suction head, small (8), and for the aspiration ligature instrument for haemorrhoids (B), which cannot be disassembled, is the same. Connect the connection tube to the tube connector (2) of the aspiration ligature instrument for haemorrhoids (A) and to the vacuum pump.

6.1.1

Attaching suction head (7) to aspiration ligature instrument for haemorrhoids (A) Depending on the size of the haemorrhoids or polyp to be ligated, attach suction head, large (7), or suction head, small (8).

7

Slide the suction head, large (7), through pusher sleeve (4) and screw it onto the thread (Fig. 2). Actuate lever (3) and check the pusher sleeve (4) for easy operation.

4

Fig. 2

6.1.2

Attaching the ligature ring (10) to the suction head, large (7)

9

7

NOTE ! Make sure you observe the compatibility of loading cones (9), (14) relative to the aspiration ligature instrument for haemorrhoids (see Section 5). Insert the loading cone (9) into the suction head, large (7), as far as it will go (Fig. 3).

Fig. 3

GA--F 048

4

9

7

Positioning ligature ring (10) on suction head, large (7) Fig. 4 Slide the ligature ring (10) over the loading cone (9) and the suction head, large (7), up to the pusher sleeve (4). Check that the ligature ring (10) is properly positioned on the suction head, large (7). Remove the loading cone (9).

10 Fig. 4

4

Switch on the vacuum pump. Carry out a function check: Section 7.2

6.2

Procedure

6

7 10

Fig. 5 Place the prepared aspiration ligature instrument for haemorrhoids (A) through the working channel (tube) against the haemorrhoid or polyp to be ligated and cover the valve (6) on the handle (1) with your thumb. The haemorrhoid or polyp is aspirated and sucked into the suction head, large (7). Actuate the lever (3) to slide the ligature ring (10) off the suction head, large (7). The ligature ring (10) ligates the aspirated haemorrhoids or polyp, respectively. Release the valve (6), let go of the lever (3) and remove the aspiration ligature instrument for haemorrhoids (A).

3 1 Fig. 5

7

Checks CAUTION ! Caution if products are damaged or incomplete ! Injury may result to the patient, user or third person. 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 carry out any repairs yourself.

7.1

Visual check Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. 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 reinstated. Check the products for compatibility.

7.2

Functional check Check that the ligature ring (10) can be pushed off the suction head, large (7), easily. Check the function suction / aspiration effect in the suction channel as well as leak tightness. Cover the valve (6) on the handle (1) of the aspiration ligature instrument for haemorrhoids (A) with your thumb and check for proper suction/aspiration function (see Fig. 5).

5

GA--F 048

8

Reprocessing and maintenance IMPORTANT ! Follow the current ”Notes and instructions on the reprocessing of R. Wolf products, accessories and devices”, order no.: GA--J 020. Do not use disinfectants containing peracetic acid without corrosion protection agents, phenols or chlorine components for the reprocessing of R. Wolf products. Do not exceed the maximum exposure time specified by the manufacturer of the disinfectants used. Note! We recommend using a fine--mesh small parts sieve for machine reprocessing and sterilization of the ligature rings (10).

8.1

Disassembly before cleaning Remove the connection hose from the aspiration ligature instrument for haemorrhoids (A). Unscrew and remove the suction head, large (7) (Fig. 6).

7

Fig. 6 8.2

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning: section 8.1 Manual cleaning / disinfection Clean the parts listed below with suitable cleaning brushes and rinse through or clean out with a cleaning gun. Then dry all parts on the inside and outside with cloths and compressed air. Pusher sleeve (4) and suction head, large (7). Suction channel covering the valve (6) on the handle (1) with your thumb. Clean the system surfaces and interstices, while operating the lever (3).

4 6

6

3

Fig. 7

GA--F 048

7

6

8.3

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning: section 8.1 Machine cleaning / disinfection Pre--clean the parts manually before machine cleaning: section 8.2. Connect the tube connector (2) of the aspiration ligature instrument for haemorrhoids (A) with the washer.

8.4

Checks Perform a visual check: section 7 and 7.1

8.5

Sterilization Sterilize the suction heads (7), (8) separately from the aspiration ligature instrument for haemorrhoids (A).

8.5.1

Steam sterilization CAUTION ! Only steam sterilize the ligature rings (10) ! Steam sterilization at 134°C (272°F) using the fractional pre--vacuum method.

8.5.2

Sterilization processes Steris

and Sterrad

NOTE ! The Steris and Sterrad sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility. For information about possible limitations, such as discoloration of plastic materials, as well as further notes see the latest version of ”Notes and instructions on the reprocessing of R. Wolf products, accessories and devices”, order no. GA--J 020. Efficacy has been certified by the sterilizer manufacturers in microbiological tests. Follow the manufacturer’s instructions. NOTE ! Steris sterilization procedure: Connect all channels to the system to ensure thorough reprocessing. Follow the manufacturer’s instructions.

7

GA--F 048

9

Technical data and order data Model / type no.

Designation, Technical data

A

8323.00

SUCTION LIGATURE INSTRUMENT WL 145MM

B

8324.00

SUCTION LIGATURE INSTRUMENT WL 340MM

Item

10

Illustration

Spare parts and accessories Item A

Illustration

Model / type no.

Designation, Technical data

Aspiration ligature instrument for haemorrhoids, removable suction head

7

8323.10

SUCTION HEAD LARGE

8

8323.11

SUCTION HEAD SMALL

9

8323.91

LOADING CONE WL 53MM

B

Aspiration ligature instrument for haemorrhoids, firmly attached suction head

14

8324.91

LOADING CONE WL 53MM

A, B Aspiration ligature instrument for haemorrhoids 10

8323.901

LIGATURE RING (100 / pkg)

6.06

CLEANING BRUSH Ø 5MM TL 240MM

6.12

CLEANING BRUSH Ø 12MM TL 700MM

-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.

11

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 ! We recommend using the original packaging material to prevent damage during transport or shipment of the products.

11.1

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

GA--F 048

8