Endoscopic Hysterectomy 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 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 1405 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

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Contents 1 1.1 1.2 1.3

Intended use... The tube... The mandrin... The instrumentation insert...

1 1 1 1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

2

5 5.1

Illustration... Legend and identification...

3 3

6 6.1 6.1.1 6.2 6.2.1

Use... Preparation... Introducing the mandrin into the tube:... Functional principle... Tube combined with mandrin...

4 4 4 5 5

7 7.1 7.2

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

8 8 8

8 8.1 8.2 8.3 8.4 8.4.1 8.4.2

Reprocessing and maintenance... Manual reprocessing... Machine reprocessing... Checks... Sterilization... Steam sterilization... STERIS und STERRAD sterilization procedures...

9 9 9 9 9 9 9

9

Technical data and order data...

9

10

Spare parts and accessories...

9

11 11.1

Operating, storage, transport and shipping conditions... 10 Disposal of product, packaging material and accessories... 10

12

Literature... 10

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1

Intended use The instrument set consisting of vaginal tube, mandrin and instrumentation insert is used to support TLH (total laparoscopic hysterectomy) .

1.1

The tube In TLH the vaginal tube is used for visualization of the cervical portio. The distal section of the vaginal tube can be seen during laparoscopically assisted vaginal hysterectomy, and thus serves the surgeon as a guide and support during cutting. The tube allows pneumoperitoneum to be maintained during cutting and opening of the posterior vaginal vault.

1.2

The mandrin The mandrin supports the introduction of the tube into the vagina. Prior to introduction it is inserted into the vaginal tube and locked in place.

1.3

The instrumentation insert The instrumentation insert has two openings -- instrument ports -- through which surgical instruments are inserted into the vaginal tube without loss of gas.

2

Indications and field of use For the use of the uterus manipulator in endoscopic hysterectomy: Uterus myomatosis Abnormal uterine bleeding NOTE ! We recommend reading relevant literature regarding the planned use. see also section 13 “Literature”

3

Contraindications Contraindications described in the relevant literature must be observed. Diagnosis and treatment of a pelvic mass that is too large to fit intact into an impermeable sack (±8 x 5 in.). Laparoscopic Hysterectomy is not indicated when vaginal hysterectomy is possible. The medical status of the patient may prohibit surgery. Anemia, diabetes, lung disorders, cardiac disease and bleeding diathesis must be evaluated before surgery. Age should rarely be deterrent. Cesarean hysterectomy is an absolute contraindication. Placenta accreta, uterine atony, unspecified uterine bleeding and uterine rupture are relative contraindication for peripartum hysterectomy at present. Another contraindications might be stage III ovarian cancer that requires a large abdominal incision. Inexperienc of the surgeon is a contraindication to the laparoscopic approach.

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Combinations CAUTION ! Be careful 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 uses and relevant technical data (working length, diameter, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product.

Instruments of 10 mm diameter can be introduced through the instrument ports without loss of gas. It is preferable to use the vaginal tube in conjunction with the uterus manipulator (8370.501). The accessories meet the Richard Wolf Standard.

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5

Illustration 1.1

#

1

3.1 3.4 3.2 3.5

2.4

3 2.1 2.3

3.3

2 # 2.2

5.1

Legend and identification Item

Designation

Item

Designation

1

Mandrin (8983.111)

3

Instrumentation insert (8983.201)

1.1

Bayonet catch, mandrin

3.1

Bayonet catch, instrumentation insert

3.2

O--ring (15 364.066)

2

Vaginal tube (8983.011)

3.3

Instrument ports, two

2.1

Bajonet catch, vaginal tube

3.4

Sealing cap without hole (89.21)

2.2 2.3

Positioning aid on vaginal tube Distal section

3.5

Sealing cap with instrument access point (89.08)

2.4

Insulation

#

Lot no.

Symbols

Designation Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number

Lot identification number

SN

Serial number Identification in conformity with Medical Devices Directive 93/42/EEC only valid if the product and/or packaging are marked with this symbol. Products of category IIa and above, as well as sterile products or products with measuring function in category I, are additionally marked with the code number of the notified body (0124).

3

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Use CAUTION ! The products have only 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.

6.1

Preparation Prior to the operation make sure all the necessary instrument components are ready to hand. The way the instruments are put together is determined by the method the surgeon uses. To assist the surgeon a positioning aid (2.2) is affixed to the vaginal tube (2). The positioning aid (2.2) corresponds with the protruding tip of the tube (distal section 2.3). Put sealing caps (3.4) and (3.5) on the instrumentation insert. Have a further sealing cap (3.4) ready to hand -- to allow gas--tight use of the tube without the uterus manipulator.

6.1.1

Introducing the mandrin into the tube: Introduce the mandrin (1) into the vaginal tube (2) and turn in the direction of the arrow as far as it will go. The mandrin is locked in place.

1

2

2.1

1.1

2.3

2.2

NOTE ! The vaginal tube (2) can also be used without a mandrin (1).

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6.2

Functional principle

6.2.1

Tube combined with mandrin Insert the mandrin (1) in the vaginal tube (2) and lock it in place by means of the bayonet catch (see chap. 6.1.1). Now introduce the tube into the vagina. Replace the mandrin (1) with the instrumentation insert (3). Join and lock the instrumentation insert and the vaginal tube together so that a gas--tight connection is created. Introduce the uterus manipulator (A) with the uterus probe (B), turning it slightly, into the instrument port (3.3). The connection is gas--tight as soon as the articulation (A.1) of the uterus manipulator (A) has passed through the instrument port (3.3).

3 3.3

A.1

B

2

A

2.2

A positioning aid (2.2) has been affixed to the vaginal tube (2) to assist the surgeon. Continue to insert the uterus manipulator (A) with the vaginal tube (2) until the distal section of the tube can be seen through the laparoscope. The vaginal vault is now opened laparoscopically (C), e.g.using the unipolar needle electrode 8383.426 (D). IMPORTANT ! For laparoscopic access to the vaginal roof do not use a CO2 laser !

D

C

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The cervical portio is made visible with a suitable grasping forceps (E).

E

Introduce the uterus probe (B) into the cervical canal under laparoscopic control and secure the uterine opening (F).

B

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F

6

The posterior vaginal vault stretches over the node--shaped tip of the tube (2.3). The surgeon, working with a laparoscope, sees this and can cut with HF scalpel exactly along the contour that has become visible. During this transabdominal endoscopic hysterectomy the vaginal tube (2) is needed as a guide and support.

F 2

2.3

A

Rotating the vaginal tube (2) and manipulating the uterus with the uterus manipulator (A), the surgeon cuts the uterus free.

2 A

As the vaginal tube (2) is gas--tight, pneumoperitoneum is also maintained after the posterior vaginal vault has been opened until the uterus has been cut completely free. After removal of the uterus the sealing cap with hole (3.5) is replaced with a sealing cap without hole (3.4). After the vaginal tube has been reintroduced, pneumoperitoneum is established again. Any remaining sources of bleeding are treated. The wound is then sutured.

7

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Checks CAUTION ! Be careful if products are damaged or incomplete ! Injury may result to the patient, user or others. 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 do any repairs yourself.

7.1

Visual check

3.4 3.2

3.5

Check the instrument, in particular its distal area, and accessories for: damage sharp edges not in conformity with the application loose or missing parts rough surfaces.

Check O--ring (3.2) and sealing caps (3.4 and 3.5) for proper fit, brittleness and damage. Make sure the O--ring (3.2) is not twisted in its groove. Check distal section (2.3) of the vaginal tube (2) for damage and make sure surface is even.

2

2.3

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 restored.

7.2

Functional check Check that the bayonet catches (1.1, 2.1 und 3.1) on the mandrin (1), vaginal tube (2) and instrumentation insert (3) function properly.

1.1 1 3 3.1

2.1

2

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8

Reprocessing and maintenance IMPORTANT ! Further information on the reprocessing is described in Manual GA--J020 “Reprocessing of RICHARD WOLF Heat Stable Instruments” and these instructions must be followed.

8.1

Manual reprocessing Wet preparation at the point of use Manual cleaning / disinfection

8.2

Machine reprocessing Dry preparation at the point of use Machine cleaning / disinfection

8.3

Checks Perform a visual check: sections 7 and 7.1

8.4

Sterilization

8.4.1

Steam sterilization Steam sterilization at 134°C (273°F) using the fractional pre--vacuum method. STERIS und STERRAD sterilization procedures

8.4.2

NOTE ! The STERIS  and STERRAD  sterilization procedures have been approved for use on our endoscopes and endoscopic accessories only with regard to material compatibility.

9

Technical data and order data 3 8983.201

10

INSTRUMENT PORT passage 2x 10 mm

Spare parts and accessories Item

Illustration

Product no.

Designation, Technical data

3.2

15 364.066

O--ring

3.4

89.21

3.5

89.08

SEALING CAP WITHOUT HOLES red--orange, 10/pkg SEALING CAP CAP 9.5--10.1MM red, 10/pkg

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.

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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.

11.1

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.

12

Literature IMPORTANT ! As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed of all new developments in this field. The Role of Laparoscopy in Hysterectomy, Harry Reich M.D; Advances in Obstetrics and Gynecology, Vol 1, 1994, Mosby--Year Book, Inc.

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