Mini Fiber Laparoscope Instruction 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

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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 6.1.1 6.1.2 6.2 6.2.1 6.3 6.4 6.5

Use... Preparation... Veres cannula... Inserting veres cannula (3) in outer sheath (2)... Abdominal laparoscopy... Alternative method... Transvaginal hydrolaparoscopy... Diagnostic hysteroscopy... Additional instructions for use...

3 3 3 3 4 5 6 7 8

7 7.1 7.2

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

9 9 9

8 8.1 8.2 8.3 8.4 8.5 8.5.1 8.5.2

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

10 10 10 10 11 11 11 11

9

Technical data and order data... 12

10

Spare parts and accessoriess... 12

11 11.1

Operating, storage and transport and shipping conditions... 12 Disposal of product, packaging material and accessories... 12

12

Literature... 13

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1

Intended use The Miniature Laparoscope Set serves to apply and manintain pneumoperitoneum and to visualize the inside of the patient via surgically created passages. The Mini Hysteroscope serves to visualize the cervical channel and the Cavum Uteri via the natural passage.

2

Indications and field of application Minimally invasive abdominal or transvaginal diagnostics and therapy (2nd incision) of unclear processes in the abdominal area (laparoscopy and hydrolaparoscopy) or uterus (diagnostic hysteroscopy). The products must be applied by adequately trained and qualified medical personnel. NOTE! We recommend reading relevant literature on the planned use. (see also chapter 12 „Literature“).

3

Contraindications Contraindiactions can result either from the general findings or from previous operations in the abdominal area (adhesions). 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 Miniature Laparoscope Set is used in connection with light sources and flexible light cables, an insufflator or a pump, cameras and objective lenses as well as endoscopic accessories (forceps, electrodes, etc.). CAUTION! When different products are combined it is necessary that they are compatible in their intended use and relevant technical data (working length, diameter, etc.). Observe the instruction manuals of the products used in combination with this product. The cold light connector (1.3) can be unscrewed and replaced with suitable adaptors to connect flexible light cables of other manufacturers. For order data please refer to the corresponding catalog page.

1.3

1

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Illustration

1.1

1.4

1.3

1.2 1.8

1.5

2.5

1

1.7 # 2.1

2.3 2.2 1.6 2.4

2

#

3

3.1

3.3 3.2

3.5 3.4

8754.xxx

3.6

5.1

#

Legend and identification Item

Designation

Item

Designation

1 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8

Mini Fiber Endoscope Objective window Sheath tube Light connector Colored ring: code for viewing direction blue: 0 Eyepiece funnel Indication of viewing direction Groove Diameter of flexible light cable

#

Model/type no.

2 2.1 2.2 2.3 2.4 3 3.1 3.2 3.3 3.4 3.5 3.6

Outer sheath Sheath tube Insufflation stopcock Yoke Pin Veres cannula Outer part of cannula Knurled nut Compression spring Threaded sleeve Insufflation stopcock Groove

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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 (Chapter 8.4) Run through the checks (Chapter 7) Tighten knurled nut (3.2).

6.1.1

Veres cannula Screw on outer part of cannula (3.1), fig. 1 fig. 1

3.1

8754.

6.1.2

Inserting veres cannula (3) in outer sheath (2) To lock: Insert veres cannula (3) in outer sheath (2). The grooves (3.6) and the pins (2.4) are aligned, fig. 2a. Push together until the clamping mechanism engages automatically, fig. 2b

fig. 2 2.4

3.6

fig. 2b

fig. 2a

3

2

8754.

To release: Push yoke (2.3) in direction of arrow and remove veress cannula (3), fig. 3.

fig. 3

8754.

2.3

3

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6.2

Abdominal laparoscopy Place the veress cannula (3) with the outer sheath (2) fitted in the abdomen. Perform the usual tests to ensure free position in the abdominal cavity. Connect the gas supply line to insufflation stopcock (3.5). fig. 4

3.5

2.2

Open insufflation stopcock (3.5) and establish pneumoperitoneum. NOTE! The insufflation stopcock (2.2) on the outer sheath (2) is closed, fig. 5.

fig. 5

close

open

After establishing pneumoperitoneum, loosen and remove veres cannula (3) from outer sheath (2). The outer sheath (2) remains in the abdomen. Insert Mini Fiber Endoscope (1) in outer sheath (2), fig. 6. The grooves (1.7) and the pins (2.4) are aligned, fig. 6a. Push together until the clamping mechanism engages automatically fig. 6a CAUTION ! Danger of breakage if locking mechanism is not engaged ! When manipulating the instrument during operations the entire force will act on the sheath (1.2) and can lead to breakage. In this case the intervention must be interrupted or discontinued. Before use make sure that the connection is properly locked !

fig. 6

2.4 1.7 1

fig. 6a 2

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Connect suitable flexible light cable. Connect insufflation tube to insufflation stopcock (2.2).

Fig. 7

Flexible light cable

2.2

Insufflation tube

IMPORTANT ! During the change--over from the veres cannula (3) to the Mini Fiber Endoscope (1) gas will leak from the outer sheath (2) still in place. It is therefore necessary to connect the insufflation tube to the insufflation stopcock (2.2) on the outer sheath. In this way any gas loss can be compensated immediately. Attach the camera to the Mini Fiber Endoscope and focus. The scope is now ready for endoscopic orientation. NOTE: The Mini Fiber Endoscope (1) can also be inserted with the camera attached.When doing so ensure correct axial alignment to prevent damage to the Mini Fiber Endoscope. Due to its very small dimensions the objective lens is easily soiled and the vision impaired. In the case of impaired vision remove the Mini Fiber Endoscope and clean the objective lens with a moist swab. 6.2.1

Alternative method Place veres cannula (3) together with outer sheath (2) in the abdomen. Perform adequate tests to ensure free position in the abdominal cavity. Disconnect veres cannula (3) from outer sheath (2) and remove. NOTE: The outer sheath (2) must remain in the abdomen. Connect gas supply tube to insufflation stopcock (2.2) of outer sheath (2). Insert Mini Fiber Endoscope in outer sheath (2). For procedure see page 4. Attach camera to Mini Fiber Endoscope (1) and focus. After checking the correct intraperitoneal position, open insufflation stopcock (2.2) and establish pneumoperitoneum.

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6.3

Transvaginal hydrolaparoscopy IMPORTANT ! The user must select the adequate dilation medium e.g. saline, and determine the quantity required for the application.

fig. 8

Introduce veres cannula (3) together with the outer sheath (2). Introducing some drops of saline indicates correct position of veres cannula. Disconnect veres cannula (3) from outer sheath (2) and remove. The outer sheath remains in situ. Insert the Mini Fiber Endoscope (1) in outer sheath (2). For procedure see page 4. Start diagnostics under supply of liquid. NOTE: We recommend reading relevant literature on the planned use (see also Chapter 11 „Literature“).

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6.4

Diagnostic hysteroscopy IMPORTANT ! Insert outer sheath (2) completed with Mini Fiber Endoscope (1) under endoscopic control.

fig. 9

0

2

1

2.2

To replace the dilation medium, close insufflation stopcock (2.2), open the connection between outer sheath (2) and Mini Fiber Endoscope (1) and pull out Mini Fiber Endoscope (1) slightly. IMPORTANT! Open insufflation stopcock (2.5) when inserting the outer sheath (2). The distal liquid jet dilates the passage thus facilitating insertion of the Mini Fiber Endoscope. Insufflation stopcock (2.2) serves to control the flow. Flow control via irrigation height (1.40 -- 2.00 m over operating height) or hystero pump setting. WARNING ! Danger of Fluid Overload Syndrome! When using a liquid dilation medium there is the danger of a Fluid Overload Syndrome! As due to its design the extremely thin (8.5 Fr.) external sheath does not have a drain channel, the liquid is normally drained via the gap between the cervical channel and the external sheath. Even if the cervical channel is very narrow, the pressure cannot become higher than preselected, but the visibility may suffer. If vessels are open (which is normally not the case in diagnostic interventions), do not introduce more than 1 liter of irrigation fluid.

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6.5

Additional instructions for use CAUTION! The products have only limited strength! Applying excessive force will lead to damage, impair the function and thus endanger the patient. Immediately before and after the application check the products for damage, loose parts and completeness. Ensure that no instrument parts remain in the patient. IMPORTANT! Use only products with classification F applied parts in conjunction with the endoscope. For maximum light efficiency and to limit the generation of heat, use a light cable with a cross--section of 2.5 mm. WARNING! Generation of heat due to high light energy. Small distances between the light exit area and tissue can destroy the tissue. Do not touch the light exit area and avoid direct contact with tissue. Fire hazard! Do not lay down the light exit area on heat- sensitive, flammable surfaces (dark drapes, etc.) as this can cause inadmissibly high temperature or ignition. Switch off the light source if you do not use the endoscope for some time. WARNING! Leakage currents! Patient leakage currents can add up if endoscopes with energetically driven endoscopic accessories or other electrically operated products are connected to the endoscope. Danger of electric shock! Measure/check the combination.

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7

Checks IMPORTANT! Run through the checks before and after every use. IMPORTANT! Do not use damaged instruments. Return damaged instruments for repair. Do not attempt to do any repairs yourself.

7.1

Visual check Before and after each use check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. Any lettering or identification required for safe use as intended must be legible. Missing or illegible lettering or identification which may lead to incorrect handling or reprocessing need to be replaced. Check bevelled end of outer part of cannula (3.1) for damage, fig.10

Fig. 10

IMPORTANT ! Discard bent veres cannula (3) and outer sheath (2) immediately and replace. The patient can be injured due to reduced function or breakage.

7.2

Function check Check snap--in mechanism of veres cannula (3): Hold veres cannula by the grip sleeve (2.5) and pull off insufflation stopcock (3.5) in direction of arrow, fig.11. When you let go of the insufflation stopcock (3.5) it immediately returns to home position. Repeat procedure several times.

fig. 11

2.5

3.5

Check veres cannula for open passage (patency): Connect the veress cannula to an insufflation device and measure the insufflation pressure. The pressure must not exceed 10 mmHg. (corresponding to the resistance of the needle at 1 l/min). Pressures exceeding this value indicate impaired patency and lead to wrong measurement of the intraabdominal pressure.

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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.

8.1

Manual reprocessing Decontamination by immersion Disassembly before cleaning Unscrew cold light connector (1.3), fig. 12.

fig. 12

Unscrew outer part of cannula (3.1), Fig. 13.

fig. 13

3.1

8754.

Unscrew and remove knurled nut (3.3). Remove compression spring (3.3) Remove threaded sleeve (3.4).

fig. 14

3.2

3.3

3.4

Manual cleaning / disinfection

8.2

Machine reprocessing Dry preparation for reprocessing. Disassembly before cleaning Same procedure as described under ”manual reprocessing” Machine cleaning / disinfection

8.3

Checks see chapter 7.

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8.4

Assembly before sterilization NOTE ! To prevent stress cracks and to ensure unimpeded steam access, slacken off knurled nut (3.2) at least one full turn before steam sterilization. Firmly tighten the connection before use. Mini Fiber Endoscope (1): Screw on connector for cold light (1.3). Veres cannula (3), Fig. 15 Slide on threaded sleeve (3.4). Ensure that pin (d) engages in groove (e). Slide on compression spring (3.3). Screw on knurled nut (3.2).

Fig. 15

3.2

3.3

3.4 d

e 8.5

Sterilization

8.5.1

Steam sterilization Steam sterilization at 134°C (272°F) using the fractional 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.

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Technical data and order data Illustration

Model/type no.

Designation, Technical data

8754.401

TELESCOPE 0 Ø 2MM WL 268MM

8754.201

VERES CANNULA Ø 2.3MM WL 250MM

8754.211

VERES CANNULA Ø 2.3MM WL 274MM

8754.221

OUTER SHEATH Ø 2.8MM WL 250MM

8754.451

TELESCOPE 0 Ø 2MM WL 158MM

8754.202

VERES CANNULA Ø 2.3MM WL 170MM

8754.212

VERES CANNULA Ø 2.3MM WL 164MM

8754.222

OUTER SHEATH Ø 2.8MM WL 141MM

8754.

8754.

8754.

8754.

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Spare parts and accessoriess Illustration

Model/type no.

Designation, Technical data

886.00

LUER LOCK CONNECTOR

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.

11

Operating, storage and 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. For the disposal observe the regulations and laws valid in your country. For further information please contact the manufacturer.

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Literature IMPORTANT! As we cannot provide a comprehensive bibliography we would ask users to keep themselves informed of all new developments in this field. Transvaginal Hydrolaparoscopy R. Campo, S. Gordts, L.Rombauts, I. Brosens (1999) Infertility and reproductive medicine, Vol. 10 No.1, 1047 -- 9422. Microsurgery: micro-- and mini--instruments. Bonnet L., Fett V., Wagner S. (1998) Min Invas Ther & Allied Technol, 7(3), 195--200. Miniature fiber endoscopes offer a clear view inside the body. Chinnock C. (1995) Laser Focus Word. Safety and Feasibility of a New Minimally Invasive Diagnostic Laparoscopy Technique Helmreich--Becker I., Meyer zum Büschenfelde K.H., Lohse A.W. (1998) Endoscopy, 30 (9), 756--762 Internistische Minilaparoskopie Lohse A.W. (1998) Broschüre Richard Wolf GmbH B693. VII 98.D.1 Office mini--hysteroscopy Campo R., van Belle Y, Rombauts L, Brosens I., Gordts S. (1999) Human Reproduction Update, Vol. 5 No. 1, 73--81 Hysteroscopy in the management of abnormal uterine bleeding Obstetrics and Gynecology Clinics of North America, Vol. 26 No.1, 0889--8545.

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