PANOVIEW PLUS Hysteroscopes Instructions

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.

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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 middle.east@richard- wolf.com www.richard- wolf.com

0

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 india@richard- wolf.com www.richard- wolf.com

GA-E 200

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...

3 3

6 6.1 6.1.1 6.2 6.3 6.4 6.4.1 6.4.2 6.4.3 6.4.4 6.4.5

Use... Preparation... Inserting the hysteroscope in the handle... Continuous flow... Dilation using C02... Additional instructions for use... Light... Electric current... HF applications... Laser applications... Irrigation fluid...

4 4 5 6 7 8 8 8 8 9 9

7 7.1 7.2

Checks... 9 Visual check... 9 Functional check... 10

8 8.1 8.1.1 8.2 8.3 8.4 8.5

Reprocessing and maintenance... Disassembly before cleaning... Stopcock plug... Machine reprocessing in reprocessing basket/tray... Assembly before sterilization... Sterilization in the reprocessing basket... Reprocessing procedure...

9 9.1

Technical data and order data... 16 HYSTEROSCOPE BNDL 89864021... 16

10

Spare parts and accessories... 16

11 11.1

Operating, storage, transport and shipping conditions... 17 Disposal of product, packaging material and accessories... 17

12

Literature... 18

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11 11 11 12 13 13 14

I

1

Intended use

2

Indications and field of use

Gynecology The Universal Operating Hysteroscope Set is used for visualizing and dilating the cervical channel, the cavum uteris and the tubal ostia (using fluid or CO2 gas). The scope is applied via the natural passage. Urology The miniature compact hysteroscope serves as a cystoscope to visualize the bladder, urethra and ureters via the natural passage.

These products may only be applied by adequately qualified and trained medical personnel.

.

NOTE ! We recommend reading relevant literature regarding the planned use (see also section 12 “Literature"). Gynecology For examination, diagnostics and therapy in conjunction with endoscopic ac­ cessories in gynecology. The use is indicated in the following cases: Z Abnormal bleeding. Z Fertility problems. Z Pain in the lower abdomen. Z Myomas, polyps Urology For examination, diagnosis and therapy of the urogenital tract in conjunction with endoscopic accessories.

3

Contraindications

4

Combinations

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.

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 prod­ uct. Compact Continuous-Irrigation Operating Hysteroscopes are used in conjunction with the following: Z Light source and flexible light cable Z Cameras and objective lenses Z Hystero Pumps or Hystero-CO2 Pneus (automatic insufflators) Z Endoscopic accessories ' see the latest catalog sheets and brochures

1

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The cold-light connector (6) can be unscrewed and replaced by suitable adapters to connect light cables of other manufacturers. For order data please refer to the latest catalog pages.

6

Fig 1

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2

5

Illustration

# 4

8

6 5

1

9

8977.411

18

2

16

12 17

5

Ansicht X

5.1

13 14 15

10/11/12

1 8986.401

10

X

2 3

11

3

Abb. 2

7

Legend and identification Item

Designation

Item

Designation

1

Objective lens

10

Stopcock for instrument port, disassemblable

2

Light exit

11

Irrigation stopcock, disassemblable

3

Working channel

12

Drain stopcock, disassemblable

4

Irrigation / suction holes (nur 8977.411)

13

Stopcock plug

5

Size of fiber bundle diameter

14

Stopcock housing

6

Cold- light connector

15

7

Color coding ring, orange (8977.411) Identification: Direction of view 12_ Color coding ring, red (8986.401 /8986402) Identification: Direction of view 20_ and 30°

Luer fitting Identification of passage on: [1,8mm / 3mm] -Stopcock housing [2 dots / 3 dots] -stopcock plug [2 pegs / 3 pegs]

16 17

Passage in Fr.

8

Eyepiece cup

18

Direction of view

9

Sealing cap

#

Product number

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 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).

3

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6

Use CAUTION ! The products have only limited strength ! Exerting excessive force will cause damage, impair the function and thus en­ danger 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 Z Check assembly (section 8.3) Z Keep measuring system ready. Z Install the sealing cap (9) (fig. 3) Z Perform a visual check (section 7 and 7.1) Z Connect the irrigation tube to the irrigation stopcock (11), (fig. 4). Z Connect the drain tube to the drain stopcock (12), (fig. 4)

11

9 Fig. 3

A

Fig. 4

12

Z Connect the flexible light cable (A) to the cold-light connector (6) (fig. 4) and the other end to a suitable light source

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4

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IMPORTANT ! To obtain optimum light transmission, the diameters of the fiber core of the endo­ scope and of the light cable must be the same. If the light cable diameter is too large, the coupling point with the endoscope may become excessively hot. If the light cable diameter is too small, the light output is reduced. The model / type number of the flexible light cable (cable) 8061.xxx / 8062.xxx serves to select the corresponding fiber core diameter that suites the endoscope: The code number (5) for the fiber core diameter on the cold-light connector (6) must correspond with the two digits to the right of the decimal point of the product number. (Fig. 5)

6 2

5

5

Fig. 5 CAUTION ! Intense heat due to high light energy ! In the case of unfavorable combinations, using the highly temperature-resistant flexible light cable 8063.353 can cause a temperature increase at the coupling point between the flexible light cable and the endosope. The user may get burns and the endocope can become damaged. Reduce the light output, if necessary use flexible light cable with product no. 8061.xxx / 8062.xxx. 6.1.1

Inserting the hysteroscope in the handle Fig. 6 Z Turn the locking lever (A) to position “I".(12:00 position). Z Insert the hysteroscope in the handle locking mechanism in such a way that pin (a) engages in groove (b). Z Turn the locking lever (A) to position “II". (2:00 position) The two components are locked together.

A b

I

II a

Fig. 6 Z Perform a functional check (section 7.2)

5

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6.2

Continuous flow

.

NOTE : Open the irrigation stopcock when inserting the hysteroscope. The liquid dis­ charged distally as a jet will dilate the passage and facilitate insertion of the hys­ teroscope. The irrigation tube must be free of air bubbles. The drain stopcock (12) serves to control pressure. OPEN: High flow  low pressure CLOSE: No flow  high pressure. The pressure is regulated by varying the irrigation height (i.e. fluid level 1.40 m 1.65 m above operating level) or by adjusting the Hystero Pump. WARNING ! If a liquid is used as dilation medium there is the risk of a fluid overload syndrom. Carefully monitor the fluid balance. Stop the operation if the fluid difference reaches 1 liter ! Figure 7, Connection diagram for continuous flow

11

12

Fig. 7

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6

6.3

Dilation using C02

.

NOTE : Open the irrigation stopcock (12) when you insert the hysteroscope. The CO2 gas discharged distally will dilate the passage and facilitate insertion of the hyster­ oscope. The pressure is controlled via the "Hystero CO2 Pneu" automatic insuf­ flator. WARNING ! Danger if air is in the irrigation system! Danger of embolism ! Before use, purge the irrgation system at a flow of 100 ml/min for a minute. Figure 8, Connection diagram for CO2 flow

11

Fig. 8

7

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6.4

Additional instructions for use

6.4.1

Light

.

IMPORTANT ! Use only products with type BF applied parts in conjunction with this endoscope. WARNING ! Accumulation of heat due to high light energy! Danger of inadvertent tissue damage due to insufficient distance between the light exit area and the tissue. Do not touch the light exit area and avoid direct contact with the tissue. WARNING ! Fire hazard! Do not place the endoscope onto heat-sensitive, flammable surfaces, such as dark drapes, as the extreme heat generated in the light exit area will lead to inad­ missibly high temperatures or even ignition. Lay down the endoscope at a safe place. If you do not use the endoscope for some time, switch off the light source.

6.4.2

Electric current

WARNING ! Danger of electric shock due to leakage currents! Patient leakage currents can add up if the endoscope is combined with powered endoscopic accessories. Make sure that such combinations do not exceed the permissible patient leakage currents.

6.4.3

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 ! Danger of injury if the HF instrument is not in the surgeon's field of view, i.e. not visible through the scope! Inadvertent tissue damage as well as damage to the distal end of the endoscope and to instrument parts is possible. Activate HF instruments only if the live HF part is fully visible through the scope and in contact with the target tissue. WARNING ! HF arcing! Danger of injury from HF applications not fulfilling the intended use or insufficient distance between live HF instruments and other conductive (endoscope) parts. 10 mm

When activated, live HF parts of HF instruments must be kept at a safe distance of at least 10 mm from the distal end of the endoscope (Fig. 9).

Fig. 9

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8

6.4.4

Laser applications

When using lasers, follow the laser device manufacturer's notes and instructions as well as the general regulations on the use of lasers. Wear the required personal protection gear.

CAUTION ! Do not work without any view through the scope! Inadvertent damage to the tissue as well as damage to the distal end of the en­ doscope and of instrument parts is possible! Activate the laser only after the tip of the laser fiber has become visible through the scope and is directed at the tissue to be treated. CAUTION ! Accumulation of heat due to highly concentrated laser beam! The heat generated by the laser beam reduces the strength of instrument parts. Do not aim the laser beam at instrument parts, in particular not at plastic parts. Maintain a safe distance. CAUTION ! Danger of eye injuries! Do not work without filter attachment! Use a suitable filter attachment on the endoscope eyepiece! 6.4.5

Irrigation fluid

7

Checks

CAUTION ! Check electrical conductivity of irrigation fluid! The user must choose a low-conductivity irrigation fluid to suit the application. Do not use NaCl solution (saline) in HF applications.

CAUTION! If products are damaged or incomplete. Possible injury of 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 do any repairs yourself.

7.1

Visual check

9

Run through the following checks Z Check instruments and accessories for damage, sharp edges, loose or missing parts and rough surfaces. ' Replace the rubber cap (10) if damaged or brittle. ' Check the irrigation holes (4) for freee passage. Z 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.

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7.2

Functional check

13 14

Fig. 10

Z Check the all components for easy assembly. Z Check all connectors for secure connection. Z Check the irrigation, drain and insertion stopcocks/ports (10)(11)/(12) for easy operation. Z Rinse out the irrigation and drain stopcocks (11)/(12) with an irrigator. ' the dilation medium should form a jet at the distal end. ' in the case of gas, no pressure should be built up. Z Check that the stopcock plug (13) is securely engaged in the stopcock housing (14). Z Check the stopcocks (10/11/12) for tightness.(Fig. 10) ' Connect a supply tube, turn the stopcock plug (B) to the closed position.. ' Replace the stopcock (B) should the stopcock leak. Z Check the stopcock plug (13) for easy operation inside the stopcock housing (14). Z Check compatibility between light connector, flexible light cable and light source. Z Checking image quality and light output: Any deposits on the glass surfaces can cause the field of view to become stained or blurred which may considerably impair light transmission. ' Clean the glass surfaces with a swab soaked with alcohol (wooden swab carrier, not metal or plastic), wipe difficult-to-remove deposits with instrument cleaner* (Fig. 11).

*For the above, please also refer to the “Notes and instructions on the repro­ cessing of Richard Wolf products, accessories and devices", order number: GA-J 020.

Fig. 11 Z Hold the distal end of the endoscope towards a light source. ' Broken fibers appear as black dots in the cold-light connector (6). If more than 30% of the fibers are broken, the light output is no longer sufficient. (Fig. 12).

6

Fig. 12

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10

8

Reprocessing and maintenance

. 8.1

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

Disassembly before cleaning

Fig. 13 Z Unscrew the sealing cap (9) Z Unscrew the cold-light connector (6)

6

9

Fig. 13 8.1.1

Stopcock plug

13

Fig. 14

11

Without disassembly tool (fig. 14) Z Pull the stopcock plug (13) out of the housing. ' The stopcock plug (14) disengages from the stopcock housing (14).

14

13

Fig. 15

A

With disassembly tool (fig. 15) Z Push forward the disassembly tool as far as it will go, as shown in figure 14, and compress. ' The stopcock plug (13) disengages from the stopcock housing (14). Z Remove the stopcock plug (13).

14

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8.2

Machine reprocessing in reprocessing basket/tray

Loading the reprocessing basket (20), Fig. 17 Z Open the locking hook (20.2) ' the basket lid (20.1) pops open. Z Open and lift off the basket lid (20.1). Z Place the parts used into or onto the corresponding holders. ' Hysteroscope ' Handle ' Cold-light connector (6) Z Place the parts used into the utensils basket (20.5) ' Rubber cap (9) ' Stopcock plug (13)

15

Fig 16

Fig. 16 ' Connect the stopcock housing (3) via Luer connectors (5) to the washer / disinfector in such a way that complete rinsing of the inside is possible.

14

Z Engage the retaining hook (20.3) of the lid in the basket (20.4) and close the basket lid (20.1).

20.1

20

20.3

20.2

20.4

13

9

20.5 38044.111

6

Fig. 17

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= Rinsing tube

12

8.3

Assembly before sterilization

.

NOTE ! Screw on the threaded connections only loosely before sterilization ' to allow a sufficient flow of sterilization medium. ' to prevent stress cracks.

Tighten all screw connections before use.

Z Screw on the cold-light conector (6). Z Insert the stopcock plug (13) into the stopcock housing (14), (Fig. 18) ' The plug engages noticeably. Z Open the stopcock plug (13)

13

14 Fig. 18

. 8.4

IMPORTANT ! Do not install the sealing cap (10) for sterilization.

Sterilization in the reprocessing basket

Loading the reprocessing basket (20), Fig. 19 Z Open the locking hook (20.2) ' the basket lid (20.1) pops open. Z Open and lift off the basket lid (20.1). Z Place the parts used into or onto the corresponding holders or place the parts used into the utensils basket (20.5), respectively. Z Engage the retaining hook (20.3) of the lid in the basket (20.4) and close the basket lid (20.1) Z For sterilization, wrap the reprocessing basket/tray in a special wrapping com­ plying with the standards in your country, e.g. EN 868, or use a suitable steril­ ization container.

20.1

20

20.3

20.2

9

20.5 38044.111

20.4

Fig. 19

13

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8.5

Reprocessing procedure

The following table describes the validated reprocessing procedure for the hyster­ oscopes.

.

IMPORTANT! Before defective products are returned for repair, they must have gone through the entire reprocessing cycle. The user is obliged to make sure that the reprocessing process including the re­ sources, material and personnel is suited to reach the required reprocessing res­ ults. The state of the art and national laws require that validated processes be fol­ lowed.

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IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 “Reprocessing of RICHARD WOLF Heat-stable Instruments“ and must be followed.

Reprocessing guide: Preparation at the point of use: Transport: Precleaning: Cleaning:

Directly after use, remove any coarse soiling from the instruments. Immediately after use, rinse out hollow spaces with a 5 ml syringe filled with water. Do not use fixing agents or hot water (>40C) as this will cause residues to stick to the surfaces and may have a negative impact on the cleaning success. Safe storage, transport and shipment of the instruments to the reprocessing room in a closed container to prevent damage to the instruments and contamination of the environment. Before cleaning disassemble the hysteroscope: see sections 8.1 and 8.1.1 Rinse out the hysteroscope for 20 seconds or, in pulsed mode, with 5 pressure surges (3 - 4 bar) using a cleaning gun. Manual cleaning Machine cleaning

1.Fill the working channel (3) with cleaning solution. Place the hysteroscope in the reprocessing basket as de­ ' Immerse the hysteroscope in a cleaning solution for scribed in section 8.2. at least 5 minutes. . IMPORTANT! 2.Brush with a soft brush for at least 5 seconds to remove To avoid damage, always machine reprocess the hys­ any residues. teroscope in the reprocessing basket. 3.Rinse out the working channel (3) with a 5 ml syringe Vario-TD program (without disinfection cycle) filled with a cleaning solution. ' 4 min of pre-cleaning with cold water 4.Then rinse out the working channel (3) for 20 seconds ' Empty or, in pulsed mode, with 5 pressure surges (3 - 4 bar) ' 6 min of washing with cleaning agent at 55C using a cleaning gun. ' Empty ' 3 min of neutralization*) (<40C) ' Empty ' 2 min of intermediate rinsing with warm tap water (<40C) ' Empty *) depending on the quality of the neutralization solution,

Disinfection:

Drying:

Function check, maintenance:

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1.Immerse the hysteroscope in an approved disinfectant solution, for the exposure time refer to the manufactur­ er's instructions. ' Fill the working channel with this solution before. 2.Then rinse out the hysteroscope thoroughly for at least 15 seconds with fully demineralized water using a cleaning gun. Manual drying: Dry the hysteroscope outside with a sterile, lint-free dispo­ sable cloth or swab, and hollow spaces with filtered com­ pressed air.

add an acid based on citric acid. Carry out thermal machine disinfection following the natio­ nal requirements regarding the A0 value (see DIN EN ISO 15883).

Drying of instruments using the washer-disinfector drying cycle. If necessary, additional manual drying can be achieved using a sterile lint-free disposable cloth or swab. Dry hol­ low spaces with filtered compressed air. Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the instrument appears vi­ sually clean. Carry out a visual check: see section 7.1

14

Assembly before sterilization Sterilization:

See section 8.3 Do not apply the rubber cap (9) until just before the application. Place the hysteroscope in the reprocessing basket as described in section 8.4.

. IMPORTANT!

To avoid damage, always sterilize the hysteroscope in the reprocessing basket.

Sterilization of the hysteroscope using the fractional pre-vacuum method (ISO13060/ISO17665) following the national requirements. ' Temperature exposure time: 4 min at 134C +4°C (273F +7°F) 132°C +4°C (270F +7°F) ' Drying time: 10 - 20 min ' Maximum sterilization temperature: 138C

15

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9

Technical data and order data Product no.

Designation, Technical data

8986.401

HYSTEROSCOPE 20° Ø 5MM WL 217MM Image angle= 80° HYSTEROSCOPE 30° Ø 3.9MM WL 217MM Image angle= 76°

8986402

9.1

HYSTEROSCOPE BNDL 89864021

consisting of:

Illustration

10

Product no.

Designation

8986402

HYSTEROSCOPE 30° Ø 3.9MM WL 217MM

88.01

RUBBER CAP CAP 0.8MM, red

Spare parts and accessories Illustration

Product no.

Designation

8986.251

HANDLE FOR HYSTEROSCOPE

38044.111

REPROCESS BASKET

88.005

RUBBER CAP CAP 0.5MM, red (10/pkg) for instruments under 3 Fr. RUBBER CAP CAP 0.8MM, red (10/pkg) for instruments up to 7 Fr. STOPCOCK BNDL CAP 2.5MM Identification: 2 pegs Packaging unit = 5/pkg STOPCOCK BNDL CAP 3.0MM Identification: 3 pegs Packaging unit = 5/pkg

88.01 896.0001 896.0002

BL D

GL

38310.0001

DISASSEMBLY TOOL

886.00

LUER LOCK CONNECTOR

103.00

BELLOWS PUMP

6.04

CLEANING BRUSH Ø 2MM TL 405MM

6.061

CLEANING BRUSH Ø 1.8MM TL 610MM

The products can be combined as required provided the relevant technical data and intended uses are ob­ served. 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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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! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

11.1

17

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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