Bipolar Electrodes and Coagulation Instruments 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.

GA-S 011

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

Contraindications...

2

5

Combinations...

2

6 6.1

Illustration... Legend and identification...

3 4

7 7.1 7.1.1 7.1.2 7.1.3 7.2 7.2.1 7.2.2

Use... Preparation... Bipolar electrode... Coagulation instrument, complete, bipolar″ ∂ia. 3 mm (1.0)... Connecting the HF bipolar connection cable... Additional notes and instructions for use... Irrigation fluid... HF applications...

5 5 5 6 6 7 7 7

8 8.1 8.2 8.2.1

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

9 9 9 9

9 9.1 9.1.1 9.1.2 9.1.3 9.2 9.3 9.4 9.5 9.6 9.6.1

Reprocessing and maintenance... Disassembly before cleaning... Suction applicator (1.1)... Bipolar electrode, complete... Connecting part, bipolar (1.3) / (2.4)... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steam sterilization...

10 10 10 10 11 11 11 11 11 11 11

10

Technical data and order data... 12

11

Spare parts and accessories... 13

12 12.1

Operating, storage, transport and shipping conditions... 13 Disposal of product, packaging material and accessories... 13

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Technical description The bipolar coagulation instruments and bipolar electrodes differ in design, shape and dimensions. They comprise the following instruments: Coagulation instrument, bipolar with suction applicator Bipolar electrodes Electrode structure -- electrode head -- insulation tube -- electrode insert -- connectors, bipolar Electrode shape -- button electrode -- hook electrode -- needle electrode -- ball electrode -- stepped ball electrode -- ring electrode Bipolar forceps

2

Intended use Bipolar coagulation instruments and bipolar electrodes are used for tissue coagulation hemostasis tissue reduction when using the suction applicator in conjunction with a flexible bipolar electrode, additionally irrigation and suction are possible. Additional bipolar electrode, 5 Fr. for bipolar cutting / vaporizing e.g. for opening the ovaries in case of a PCO syndrome (polycystic ovary syndrome)

3

Indications and field of use For therapy in conjunction with endoscopic accessories in the following medical disciplines: Bipolar coagulation instruments and bipolar electrodes Surgery (e. g. plastic surgery, thorax surgery, neurosurgery) Gynecologie ENT Orthopedics Bipolar electrode, 5 Fr. Surgery, gynecologie, e. g. in case of -- abnormal bleedings -- fertility problems -- myomas, polyps (tissue reduction)

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Contraindications Contraindications are acute inflammation in the abdomen infection of the vagina pregnancy CJD -- Creutzfeldt Jakob Disease or vCJD -- Variant 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 currently unknown.

5

Combinations Bipolar coagulation instruments and bipolar electrodes are used in conjunction with: HF bipolar connection cables Pumps for irrigation and aspiration Endoscopic accessories, e. g. Operating endoscopes Trocar sleeves Specula Suction applicators Sheaths, hysteroscopes and instruments, e. g. with 5 Fr. working channel for 5 Fr. bipolar electrode IMPORTANT ! Maximum power setting on the HF bipolar generator when using the bipolar elctrode, 5 Fr., -- 60 watts the other instruments as a limit value 50 watts (recommended) CAUTION ! Do not combine products incorrectly! The patient, user or others may be injured and the product may become damaged. Different products should only be used in combination if their intended uses and relevant technical data (working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in combination with this product. Follow the ”Notes and instructions on HF applications”, order no.: GA- S 002 as well as the HF device manufacturer’s instructions.

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6

Illustration

1.1

1.4

#

1.2

1.0

1.1.1

1.3

#

* 1.3.1

2.1 2.3

2.4

#

*

2.2

1.3.4

1.3.2 1.3.3

2.0 2.4.3

2.4.1 2.4.2

3.1 3.2

#

3.3

3.0

3.4 # # #

4.0

**

5.0 6.10

6.2 6.1

# #

6.6 6.7 6.3

Fig. 1

3

6.4 6.5

6.8

6.0

6.9

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6.1

Legend and identification Item

Desigantion Coagulation instrument, complete,

1.0

bipolar dia. 3.0 mm

Item

Desigantion

4.0

Bipolar epistaxis electrode, dia. 3.1 mm

1.1

Suction applicator

5.0

Bipolar electrode 5 Fr. / dia. 1.5 mm

1.1.1

Tube connector

6.0

Bipolar forceps

1.2

Button electrode, dia. 1.8 mm

6.1

Bipolar forceps, straight, blunt

1.3

Connectors, bipolar

6.2

Bipolar forceps, straight, pointed

1.3.1

Adaptor

6.3

Bipolar forceps, angled, pointed

1.3.2

Knurled cap

6.4

Bipolar forceps, distally angled, blunt

1.3.3

Spring collet

6.5

Bipolar forceps, distally angled, pointed

1.3.4

Connecting part

6.6

Bipolar forceps, bayonet--shaped, blunt

1.4

Rubber cap ”RIWO” blue

6.7

Bipolar forceps, bayonet--shaped, pointed

2.0

Bipolar electrodes, dia. 1.8 mm

6.8

2.1

Stepped ball electrode

6.9

Bipolar forceps, angled 60°, blunt

2.2

Ring electrode

6.10

For dimension [x] see section 10

2.3

Button electrode

2.4

Connectors, bipolar

*

Electrode inserts identification on packaging

2.4.1

Knurled cap

**

Lot no.

2.4.2

Spring collet

#

Product no.

2.4.3

Connecting part

3.0

Bipolar electrodes, dia. 5.0 mm

3.1

Bipolar hook electrode

3.2

Bipolar needle electrode

3.3

Bipolar ball electrode

3.4

Bipolar needle after Binner

Symbol

Bipolar forceps, bayonet--shaped, blunt, distally angled

Desigantion Caution, consult ACCOMPANYING DOCUMENTS!

REF

Order no. Lot 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 no. of the notified body (0124).

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7

Use CAUTION ! The products have only limited strength ! Excessive force will cause damage, impair the function and therefore endager the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

7.1

Preparation Check assembly: see section 9.5 Run through the checks: see sections 8 and 8.1

7.1.1

Bipolar electrode Fig. 2 Loosen the knurled cap (1.3.2) / (2.4.1) on the adaptor (1.3.1) / connectors, bipolar (2.4) by turning in direction of the arrow.

1.3.1

Fig. 2

1.3.2

2.4.1

2.4

Fig. 3 Insert the bipolar electrode into the adaptor (1.3.1) / connectors, bipolar (2.4) as far as it will go. Tighten the knurled cap (1.3.2) / (2.4.1) on the adaptor (1.3.1) / connectors, bipolar (2.4) by turning in direction of the arrow. Pull slightly to check that the bipolar electrode is securely fastened.

1.3.1

Fig. 3

5

1.3.2

2.4.1

2.4

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Coagulation instrument, complete, bipolar″ ∂ia. 3 mm (1.0)

7.1.2

CAUTION ! Danger of burns ! Danger of burns if electrodes with wrong working length are used. Use the coagulation instrument, bipolar (1.0) only with button electrode (1.2) and connectors, bipolar (1.3).

1.1

Fig. 4 Plug the rubber cap (1.4 ) onto the suction applicator (1.1).

1.4

Fig. 4 Fig. 5 Insert the complete bipolar electrode as far as it will go. Connect the tubing to the tube connector (1.1.1).

1.2 1.3 Fig. 5

7.1.3

1.1.1

Connecting the HF bipolar connection cable Connect the HF bipolar connection cable to the connectors, bipolar (1.3) / (2.4) and the other end to the HF bipolar generator. Carry out a function check: see section 8.2

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7.2

Additional notes and instructions for use WARNING ! Danger of injury ! Never lay down the HF instrument on the patient or in the patient’s immediate environment. WARNING ! Danger of explosion and / or danger of perforation if the electrode is activated in an air or gas bubble ! Activate HF current only if: the electrode is visible through the scope. the desired tissue contact is made. IMPORTANT ! When inserting and removing the HF instrument into / from the endoscope make sure that you do not damage the endoscope.

7.2.1

Irrigation fluid CAUTION ! Irrigation fluid can be electrically conductive ! The user must choose a suitable irrigation fluid for the application. Bipolar applications: 0.9% NaCl solution (saline) CAUTION ! Temperature increase when working without irrigation fluid ! Injuries of the mucous membrane due to excessive temperatures endanger the patient.

7.2.2

HF applications Follow the ”Notes and instructions on HF applications”, order no.: GA--S 002 as well as the HF device manufacturer’s instructions. WARNING ! Careful if the HF voltage / power is set too high ! Danger of injury resulting from damage to the electrode insulation ! Exceeding the maximum recurring peak voltage for the electrode in combination with HF surgical devices and / or selecting the wrong mode can destroy the insulation and cause leakage currents. Thermal damage to the patient and / or user are possible. Use HF instruments in combination with HF surgical devices only at a maximum recurring peak voltage (Vs ) as follows. Designation

7

Mode of operation - Coagulation

Bipolar electrodes, dia. 1.8 mm

500 Vs

Bipolar electrodes, dia. 5.0 mm

800 Vs

Bipolar forceps: needle electrode

500 Vs

Bipolar electrode 5 Fr. / dia. 1.5 mm

560 Vs

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WARNING ! Danger of injury if the HF instrument is not visible through the scope ! Inadvertent tissue damage as well as damage to the distal end of the endoscope and instrument parts are possible. Use HF instruments only within the specifications (mode). Activate HF instruments only after the part conducting HF current has become fully visible through the scope and contact is made with the desired area of use. WARNING ! HF arcing ! Danger of injury due to incorrect HF application and insufficient distance between parts conducting live HF current and other conductive parts. Parts of HF instruments which conduct high frequency current must have a safety distance of at least 10 mm from the distal end of the endoscope during activation. CAUTION ! Careful if HF output power is incorrectly selected ! Injuries to the patient as well as damage to the product are possible. The power should be set on the basis of the surgeon’s experience / training regarding the corresponding indication. NOTE ! To determine the optimum power setting we recommend starting at a low power setting.

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Checks CAUTION ! Be careful if products are damaged or incomplete ! Injuries of the patient, user or 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 HF instruments, in particular their distal area, and the accessories for: damage sharp edges loose or missing parts rough surfaces. Any lettering, labeling or identification necessary for the safe intended use must be legible. Missing or illegible lettering, labeling or identifications which can cause wrong handling and reprocessing must be reinstated. Fig. 6 Check insulation. Replace bipolar electrode if the insulation is damaged.

Fig. 6 8.2

Function check Check the individual components for compatibility. Check for secure connections. Check suction applicator (1.1) for patency (free passage).

8.2.1

Function test Moisten sterile swab with sterile saline. Touch the swab with the bipolar electrode / coagulation instrument and activate the HF bipolar generator. The liquid in the swab must evaporate due to the heat generated. If no heat or insufficient heat is generated: Check all plug--and--socket connections. Replace faulty parts.

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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 the latter have been diagnosed, adequate measures must be taken to prevent possible transmission to other patients, users and thrid parties. For this purpose apply the country- specific reprocessing guidelines and regulations. 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.

9.1

Disassembly before cleaning Remove the HF bipolar connection cable.

9.1.1

Suction applicator (1.1) Fig. 7 Disconnect the connection tube from tube connector (1.1.1). Pull the bipolar electrode, complete out of suction applicator (1.1).

1.1

1.1.1

Fig. 7 Fig. 8 Remove the rubber cap (1.4).

1.4

Fig. 8 9.1.2

Bipolar electrode, complete Fig. 9 Loosen the knurled cap (1.3.2) / (2.4.1) on the adaptor (1.3.1) / connectors, bipolar (2.4). Pull the bipolar electrode out of adaptor (1.3.1) / connectors, bipolar (1.3) / (2.4).

1.3.1

Fig. 9

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1.3.2

1.3

2.4.1

2.4

10

9.1.3

Connecting part, bipolar (1.3) / (2.4) Fig. 10 Loosen adaptor (1.3.1) / knurled cap (1.3.2) / (2.4.1) from the spring collet (1.3.3) / (2.4.2) and spring collet (1.3.3) / (2.4.2) from connecting part (1.3.4) / (2.4.3) by turning as indicated by the arrows.

1.3.1

Fig. 10 9.2

1.3.2

1.3.3

1.3.4

2.4.1

2.4.2

2.4.3

Manual reprocessing Wet preparation at the point of use Disassembly before cleaning: see section 9.1 Manual cleaning / disinfection IMPORTANT ! Do not clean plastic parts (e. g. plastic coatings of the bipolar electrodes) with metal tools or tools that have sharp edges (e. g. brushes).

9.3

Machine reprocessing Dry preparation at the point of use Disassembly before cleaning: see section 9.1 Machine cleaning / disinfection

9.4

Checks Carry out a visual check: see sections 8 and 8.1

9.5

Assembly before sterilization NOTE ! Before sterilization screw on the threaded connections only loosely: to allow a sufficient flow of sterilization medium. to prevent stress cracks. Tighten all screw connections before use. Assemble the connectors, bipolar (1.3) / (2.4) in reverse order as described in section 9.1.3. Screw on the connectors, bipolar (1.3) / (2.4) loosely only 1 to 2 turns.

9.6

Sterilization IMPORTANT ! Do not sterilize HF instruments in hot--air sterilizers.

9.6.1

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

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Technical data and order data Item

Product no. Desigantion OL = overall length, WL = working length SL = sheath length

1.0

8801.451

Coagulation instrument, complete, bipolar, consisting of:

1.1

8801.453

Suction applicator

1.2

8801.452

Button electrode

1.3

8801.554

Connectors, bipolar

1.0

8801.551

Coagulation instrument, complete, bipolar, consisting of:

1.1

8801.553

Suction applicator

1.2

8801.552

Button electrode

1.3

8801.554

CONNECTION PART BIPO

2.0

Bipolar electrodes

2.1

8765.612

ELECTRODE BIPO Ø 1.9MM WL 400MM

2.2

8765.613

RING ELECTRODE BIPO Ø 1.8MM SL 400MM

2.3

8765.621

BUTTON ELECTRODE BIPO Ø 1.8MM SL 400MM

2.4

8765.554

Connection part bipo

3.0

Bipolar electrodes

3.1

8383.102

Bipolar hook electrode

3.2

8383.103

Bipolar needle elctrode

3.3

8383.104

Bipolar ball electrode

3.4

8211.80

HF NEEDLE BIPO Ø 2.5MM WL 101MM

4.0

8211.721

Bipolar epistaxis electrode

5.0

823005

ELECTRODE BIPO 5FR TL 360MM

6.0

Bipolar forceps 82930.0016

Bipolar forceps, straight, blunt

82930.0019

TWEEZERS DULL BIPO TL 190MM

6.2

82930.0216

Bipolar forceps, straight, pointed

6.3

82930.0416

TWEEZERS POINTED BIPO TL 165MM

82930.0616

Bipolar forceps, distally angled, blunt

82930.0816

TWEEZERS DULL BIPO TL 165MM

82930.0819

TWEEZERS DULL BIPO TL 190MM

82930.1019

TWEEZERS DULL BIPO TL 190MM

82930.1216

Bipolar forceps, distally angled, pointed

82930.1416

TWEEZERS DULL BIPO TL 165MM

82930.1419

TWEEZERS DULL BIPO TL 190MM

6.7

82930.1816

Bipolar forceps, bayonet--shaped, pointed

6.8

82930.1619

TWEEZERS DULL BIPO TL 190MM

6.9

82930.2018

TWEEZERS DULL BIPO TL 180MM

6.1

6.4

6.5 6.6

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Spare parts and accessories Item

Product no. Designation, technical data

1.4

88.02

--

8108.1xx

RUBBER CAP CAP 1.4MM HF CONNECTION CABLE BIPO

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 catalogue sheets and brochures, or contact Richard Wolf or your Richard 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.

12.1

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

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