Bronchoscopes Control Instrument Instructions Manual

Important general instructions for use Ensure that this product is only used as intended and described in the instruction manual, by adequately trained and qualified personnel, and that maintenance and repair is only carried out by authorized specialized technicians. Operate this product only in the combinations and with the accessories and spare parts listed in the instruction manual. Use other combinations, accessories and wearing 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 unit to be used or sold, except under the supervision of a medical doctor.

Safety instructions and levels of danger Symbol

Level of danger WARNING! Failure to observe can result in death or severe 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 D--75438 Knittlingen Pforzheimerstr. 32 Tel.: (+49)--(0)7043--35--0 Fax:(+49)--(0)7043--35300 MANUFACTURER E--mail: [email protected] Internet: www.richard--wolf.com

USA RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Tel.: (+1)--(0)847--913 1113 Fax: (+1)--(0)847--913 1488 E--mail: sales&[email protected] Internet: www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW 17 0HB Tel.: (+44)--(0)20--8944 7447 Fax: (+44)--(0)20--8944 1311 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)--(0)9280--8100 Fax: (+32)--(0)9282--9216 E--mail: [email protected]

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F--51100 Reims Tel.: (+33)--(0)32687--0289 Fax: (+33)--(0)32687--6035 E--mail: [email protected]

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstrasse 93 a A--1160 Vienna Tel.: (+43) (0)1-- 405 51 51 Fax: (+43) (0)1-- 405 51 51--45 E--mail: [email protected] Internet: www.richard--wolf.at

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Contents 1

Intended use... 1

2

Indications and field of use... 1

3

Contraindications... 1

4

Combinations... 1

5 5.1

Illustration... 2 Legend and identification... 2

6 6.1 6.1.1 6.1.2 6.1.3 6.1.4

Use... Preparation... Preparation/ insertion/ removal of the control instrument... Insertion/ removal of the endoscope... Preparation/ insertion/ removal of flexible instrument... Position of coil spring angle...

7 7.1 7.2

Checks... 7 Visual check... 7 Functional check... 7

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... Steris and Sterrad sterilization procedures...

9

Spare parts and accessories... 9

10

Operating, storage, transport and shipping conditions... 9

11

Disposal of product, packaging material and accessories... 9

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3 3 3 5 5 6

8 8 8 8 9 9 9 9

1

Intended use The control instrument is used to guide the endoscope, flexible forceps, scissors and cytology brush in the bronchoscope.

2

Indications and field of use For examination, diagnosis and/or therapy in ENT medicine, for example the larynx, trachea and bronchia.

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 control instrument is used in combination with bronchoscopes, endoscopes, flexible clamps, scissors, cytology brushes and 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, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction with this product. For an overview of permissible combinations of control instrument and accessories / spare parts, please refer to GA- G 117.

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Illustration

1.1

1.2

1.4 1.5

1.3

1.6

1.7

1

1.12

1.11 1.10

1.9

1.8

#

Fig. 1 5.1

Legend and identification Item

Designation

1

Control instrument

1.1

Pull--through wire

1.2

Guide tube

1.3

Fixing pin

1.4

Pin

1.5

Endoscope guide tube

1.6

Clamping lever

1.7

Clamping ring

1.8

Rubber cap

1.9

Instrument channel

1.10

Control collar

1.11

Cone adapter

1.12

Coil spring

#

Model / Type No.

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 of category I, are additionally marked with the code number of the notified body (0124).

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6

Use CAUTION! The products only have limited strength! Exerting excessive force will cause damage, impair the function and thus 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 Carry out check (section 7)

6.1.1

Preparation/ insertion/ removal of the control instrument NOTE! Insert/withdraw the control instrument only when the coil spring is straight. Observe the symbols on the circumference of the cone adapter! Turning the control collars in the direction

a

moves the coil spring towards “Basic position” (Fig. 2a) moves the coil spring towards “End position” (Fig. 2b)

b

Fig. 2

Preparation (Fig. 3) Turn control collar (1.10) as far as it will go in the direction indicated by the (counterclockwise) -- Basic position. arrow The coil spring (1.12) is straight. Pin (1.4) is retracted.

Fig. 3 1.4

1.10 1.4 1.12

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Insertion (Fig. 4) Insert the control instrument into the bronchoscope tube (A). NOTE! The fixing pin (1.3) in the cone adapter (1.11) must be inserted into the groove (a) on the bronchoscope tube (A). Press the cone adapter (1.11) onto the Wolf standard cone (b).

a

1.3

A

b

1.11

Fig. 4

Removal (Fig. 5) Hold the control instrument by the control collar (1.10) and remove it.

Fig. 5

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1.10

4

6.1.2

Insertion/ removal of the endoscope Insertion (Fig. 6) Clamping lever (1.6) is in position “I“. Insert endoscope (B). The nose (b) engages in groove (c). Turn clamping lever (1.6) to position “II“. Endoscope is locked

(b) c)

1.6

B

Fig. 6

Removal (Fig. 6) Clamping lever (1.6) is in position ”II”. Turn clamping lever (1.6) to position ”I”. The endoscope is unlocked Remove endoscope (B)

6.1.3

Preparation / insertion / removal of flexible instrument IMPORTANT! Insert / remove the flexible instrument only under visual control and when the coil spring is straight. Preparation (Fig. 7) Turn control collar (1.10) as far as it will go in the direction indicated by the arrow (counterclockwise) -- Basic position. The coil spring (1.12) is straight. Pin (1.4) is retracted.

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Attach rubber cap (1.8) to instrument channel (1.9) 7. Insertion / removal (Fig. 7) Insert / remove flexible instrument e.g. flexible biopsy forceps (C) through the rubber cap

1.10

1.12

1.4

1.9 1.8

Fig. 7

6.1.4

C

Indication of coil spring angle The position of pin (1.4) indicates three positions of the coil spring (1.12) (Fig. 8). Basic position (Fig. 8a) Control collar (1.10) is at the left stop (clockwise). Coil spring (1.12) is straight. Pin (1.4) is retracted.

a

1.4

1.10

1.12 b

1.4

c

1.12

Fig. 8

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1.4

Middle position (Fig. 8b) Control collar (1.10) is in the middle position. Coil spring (1.12) is in the middle position (45 degrees). Pin (1.4) is half--extended to notch (h).

End position (Fig. 8c) Control collar (1.10) at right stop (anticlockwise). Coil spring (1.12) is angled to approx. 90 degrees. Pin (1.4) is fully extended.

h

6

7

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 Check control instrument, in particular the coil spring, for damage, sharp edges, loose or missing parts and rough surfaces. Check rubber cap for damage, such as cracks (Fig. 9). Any labels and identification necessary to ensure usage in accordance with intended purpose must be legible Missing or illegible lettering, labeling or identification which may lead to incorrect handling and reprocessing. It must be reinstated.

Fig. 9 7.2

Functional check Check instruments for easy actuation. Check that control collar turns easily in both directions. Check angle position of coil spring. Check positions of indicator pin. Check clamping ring for easy rotation (locking and unlocking).

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Reprocessing and maintenance IMPORTANT! Follow the latest version of ”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

Disassembly before cleaning Remove endoscope (B) and flexible instrument (C) from the control instrument (1): see sections 6.1.2 and 6.1.3. Remove control instrument (1) from bronchoscope tube (A): see section 6.1.1. Remove rubber cap (1.8) from instrument channel (1.9).

8.2

Manual reprocessing Wet decontamination at the point of use. Disassembly before cleaning: see section 8.1. Manual cleaning / disinfection. Carefully clean coil spring (1.12) with cleaning brush with the coil spring in middle position (Fig. 10).

Fig. 10

1.12

Return coil spring (1.12) to basic position (straight): see section 6.1.4. Rinse endoscope guide (1.5) and instrument channel (1.9) with a spray gun and suitable cleaning brushes (Fig. 11).

1.5

1.12

1.9

Fig. 11 8.3

Machine reprocessing Dry decontamination at the point of use. Disassembly before cleaning: see section 8.1. Clean the spiral spring with a cleaning brush: see section 8.2. Machine cleaning / disinfection.

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8.4

Checks Carry out check: see section 7

8.5

Sterilization

8.5.1

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

8.5.2

Steris

and Sterrad

sterilization procedures 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 notes and information on possible restrictions, 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 manufacturer in microbiological tests. NOTE! Steris sterilization procedure: Connect all channels to the system to ensure thorough reprocessing. Follow the manufacturer’s instructions.

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Spare parts and accessories Illustration

Model / Type No. 88.02

Designation, technical data RUBBER CAP CAP 1.4MM, sky blue

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.

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

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