Medullary Space Endoscopy Set 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 14 05 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

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 [email protected] www.richard--wolf.com

GA--B 235

Contents 1 1.1 1.2 1.3 1.3.1 1.3.2 1.3.3 1.3.4 1.4

Technical description... Telescope [ A ]... Access instruments [ B ]... Working instruments [ C ]... Suction and irrigation devices (C1)... Rigid cutting instruments (C2)... Forceps and scissors (C3)... Product applied in conjunction with motors (C4)... Storage system [ D ]...

1 1 1 1 1 1 2 2 2

2 2.1 2.2 2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.4

Intended use... Telescope [ A ]... Access instruments [ B ]... Working instruments [ C ]... Suction and irrigation instruments (C1)... Rigid cutting instruments (C2)... Forceps and scissors (C3)... Product applied in conjunction with motors (C4)... Storage system [ D ]...

2 2 3 3 3 3 3 3 3

3

Indications and field of use...

4

4

Contraindications...

4

5

Combinations...

4

6 6.1 6.2 6.2.1 6.2.2 6.2.3 6.3

Illustration... 6 Operating telescope [ A ] and access instruments [ B ] (Operating tube, working sleeve, obturator)... 6 Working instruments [ C ]... 8 Suction and irrigation instruments (C1), rigid cutting instruments (C2)... 8 Forceps and scissors (C3)... 9 Product applied in conjunction with motors (C4)... 10 Storage system [ D ]... 11

7 7.1 7.2 7.2.1 7.2.2 7.2.3 7.3 7.3.1 7.3.2 7.4 7.5 7.5.1 7.5.2 7.5.3 7.5.4 7.5.5 7.6

Use... Preparation... Diagnosis / therapy -- in the area of the medullary space... Operating telescope [ A ]... Access instruments [ B ]... Working instruments [ C ]... Diagnosis and therapy -- in the soft tissue around bones... Operating telescope [ A ]... Working elements [ C ]... Applications with operating telescope 8781.403 and operating tube 8781.203... Additional notes and instructions for use... Working instruments [ C ]... Light... Current... Image quality... Irrigation fluid... HF application...

GA--B 235

12 12 12 12 14 14 15 15 16 16 17 17 22 22 22 22 23

I

8 8.1 8.1.1 8.1.2 8.2 8.2.1 8.2.2

Checks... Visual check... Operating telescope [ A ]... Working instruments [ C ]... Functional check... Operating telescope [ A ]... Working instruments [ C ]...

24 24 24 25 25 26 27

9 9.1 9.2 9.2.1 9.3 9.4 9.4.1 9.5 9.6 9.6.1 9.6.2 9.7 9.7.1 9.7.2 9.7.3

Reprocessing and maintenance... Viewing cap (1) transparent, sterile... Disassembly before cleaning... Working elements [ C ]... Manual reprocessing... Machine reprocessing... Storage system [ D ]... Checks... Assembly before sterilization... Operating telescope [ A ]... Working instruments [ C ]... Sterilization... Storage system [ D ]... Steam sterilization... STERIS und STERRAD sterilization procedures...

28 28 28 28 29 30 30 30 31 31 32 33 33 33 33

10 10.1

Technical data and order data... 34 Medullary Space Endoscopy Set by Oberst 89300.0001 consisting of... 34

11

Spare parts and accessories... 36

12 12.1

Operating, storage, transport and shipping conditions... 37 Disposal of product, packaging material and accessories... 37

II

GA--B 235

1

Technical description The Medullary Space Endoscopy Set consists of a telescope, access and working instruments as well as a storage system. The individual instruments are described in the following:

1.1

Telescope

A Operating telescope PANOVIEW PLUS 10° in the following called “Operating telescope” with sheath tube, integrated light guide, optical system and working channel with right--angled handle with eyepiece and eye cup and angled cold--light connector with lateral Luer connector for telescope rinsing Viewing cap transparent, sterile Valve insert Sealing part, complete

1.2

Access instruments

B Operating tube in the following called “Operating tube” with automatic locking mechanism and irrigation stopcock with outer tube Operating tube, rotatable with snap--in mechanism (the operating tube is plugged onto the operating telescope)

Working sleeve with tube provided with an external thread with grip for screwing the working sleeve into the femur Obturator with conical atraumatic piston with grip cannulated

C

1.3

Working instruments

1.3.1

Suction and irrigation devices (C1) Suction tubes without HF with tube, proximally angled with Luer tube fitting

1.3.2

Rigid cutting instruments (C2) Chisel with distally flattened cutting edge Chisel, distally angled with distally angled cutting edge Spoon, distally angled with distally angled spoon

GA--B 235

1

1.3.3

Forceps and scissors (C3) Biopsy forceps, unipolar consisting of jaw insert, insulated sheath tube and forceps handle with distal single--sided movable biopsy jaw section actuated via a pull rod by means of the proximal forceps handle The jaw section can be rotated freely through 360°. Grasping forceps, unipolar with two teeth consisting of internal part, insulated sheath tube and forceps handle with distally controllable single--sided movable grasping forceps jaw section actuated via a pull rod by means of the proximalforceps handle The jaw section can be rotated freely through 360°. Spoon forceps, distally angleable with distal angleable jaw section actuated via a proximal deflection lever with distal single--sided movable jaw section actuated via a pull rod by a proximal forceps handle The jaw section can be rotated freely through 360°.

1.3.4

Product applied in conjunction with motors (C4) Spherical cutter Spherical cutter to be driven by means of a motorized handle via a proximal drive dog

1.4

Storage system

D Reprocessing basket with special holders and hooks with locking mechanism with utensils basket

2

Intended use In the area of the femoral and tibial medullary space the instrument set is used for minimally invasive diagnosis and therapy. In the area of the soft tissue parts around the supporting structure the instrument set is used for endoscopic tissue preparation as well as endoscopically assisted location, removal or placement of implants.

2.1

Telescope

A Operating telescope, is used for visualization and preparation of the operating area for securing the operating tube for holding the viewing cap for inserting auxiliary instruments through the working channel into the operating area under visual control (without viewing cap) for rinsing the operating telescope and irrigating the operating area via Luer connector (without viewing cap) Viewing cap transparent, sterile, is used for atraumatic insertion of the operating telescope with operating tube into the operating area under visual control. Valve insert serves to securely connect the sealing unit with membrane valve Sealing unit, complete, is used for gas--tight insertion of auxiliary instruments up to a diameter of 5.5 mm through the working channel.

2

GA--B 235

2.2

Access instruments

B Operating tube, is used for holding and automatically securing the operating telescope in the required position for securing the viewing cap against inadvertent removal to keep the surgical passage open when removing the operating telescope for irrigating the operating area Working sleeve is screwed into the femur and serves as a passage for the operating tube Obturator facilitates inserting the working sleeve into the femur precise placement of the working sleeve via the alignment wire

C

2.3

Working instruments

2.3.1

Suction and irrigation instruments (C1) Suction tubes without HF for evacuating secretion from the operating area

2.3.2

Rigid cutting instruments (C2) Chisel / chisel, distally angled for the removal of cement residues from the femur (hip prosthesis revision) for exposing femur nails grown over with osseous tissue for sharp preparation for the removal of osseous tissue Spoon, distally angled

for the removal and withdrawal of osseous tissue 2.3.3

Forceps and scissors (C3) Biopsy forceps, unipolar for the removal of tissue parts for coagulating minor hemorrhages by means of unipolar HF current Grasping forceps, unipolar with two teeth for grasping, manipulating and withdrawing tissue parts For coagulating minor hemorrhages by means of unipolar HF current Spoon forceps, distally controllable for the withdrawal of tissue parts located distally laterally relative to the operating telescope.

2.3.4

Product applied in conjunction with motors (C4) Spherical cutter for the ablation / removal of cement residues from the femur (hip prosthesis revision) for the removal of bone tissue

2.4

Storage system

D Reprocessing basket for safe storage of the telescope (A), accessory instruments (B) and endoscopic accessories during -- transport or shipment -- reprocessing -- sterilization -- storage

GA--B 235

3

3

Indications and field of use For diagnosis and therapy in conjunction with endoscopic accessories in the area of the femur and tibia as well as the hip joint: Bone tumors Biopsies Exstirpation TU ablation Spongiosa graft Osteomyelitis / bone cysts Biopsies Exstirpation Spongiosa graft for endoscopic cement removal during revisions in the field of hip prosthetics. for endoscopically controlled intra medullary closed fracture reposition in the area of the femur. in the area of the soft tissue parts around the supporting system. for endoscopic tissue preparation. for endoscopically assisted locating, removal or placement of implants.

4

Contraindications CJD -- Creutzfeldt--Jakob Disease or vCJD -- Variant of the Creutzfeldt--Jakob Disease BSE -- Bovine Spongiform Encephalopathy; the so--called mad cow disease (e.g. Creutzfeldt--Jakob disease) TSE -- Transmissible spongiform Encephalopathy The physician/surgeon in charge must decide whether the planned use is possible or not on the basis of the patient’s general condition. Follow the regulations and laws valid in your country. For further information, see the latest medical literature. Contraindications directly related to the product are presently unknown.

5

Combinations The Medullary Space Endoscopy Set is used in conjunction with: light sources and fiber light cables pumps for irrigation and suction cameras and objective lenses HF surgical devices Motor systems / motorized handles Endoscopic accessories The instruments are selected in accordance with the indication and the surgeon’s requirements. 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, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in conjunction 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.

4

GA--B 235

Fig. 1 2.11

The cold--light connector (2.11) can be unscrewed and replaced by suitable adaptors to connect fiber light cables of other manufacturers. For the order number please refer to the latest catalog sheet.

Fig. 1

GA--B 235

5

6

Illustration

6.1

Operating telescope

A and access instruments (Operating tube, working sleeve, obturator) 2.11

B

2.12

A *

2.10

# 2.13

2.2 2.3

2.1

180° 2.15

2.9

2.4

1

2.14

2

2.5

2.6

2.7 2.8

4 5.1 5.2 5.3

2.16

5 3

3.1

#

3.6

3.2

3.3

3.5 3.4

B

#

6.1

#

6

6.2

7

7.1

Fig. 2

6

GA--B 235

Legend and identification Item Designation

Item Designation

A

Telescope

1

Viewing cap

3

Operating tube

2

Operating telescope

3.1

Tube

2.1

Irrigation nozzle

3.2

Tab with color coding

2.2

Objective lens

3.3

Locking mechanism

2.3

Light exit

3.4

Trigger

2.4

Working channel

3.5

Snap--in position

2.5

Positioning contour

3.6

Irrigation stopcock (removable stopcock plug)

2.6

Sheath tube

4

Valve insert

2.7

Annular groove

5

2.8

Locking pins

5.1

Membrane valve

2.9

Handle

5.2

Screw cap

2.10

Size indication of fiber core diameter

5.3

Sealing cap

2.11

Cold--light connector

2.12

Eyepiece with eye cup

2.13

Colored coding ring, orange (direction of view 10°)

2.14

Luer connector, female (irrigation)

2.15

Luer sealing cap

*

Serial number

2.16

Diameter on working instruments

#

Product no.

B

Access instruments

6

Working sleeve

6.1

Tube with external thread

6.2

Handle

7

Obturator

7.1

Hole for targeting wire

#

Product no.

GA--B 235

Sealing part, complete for instruments up to dia. 5.5 mm

7

C

6.2

Working instruments

6.2.1

Suction and irrigation instruments (C1), rigid cutting instruments (C2)

8 C1 8.1 8.2 #

9

#

10

#

C2

#

11

Fig. 3

Legend and identification Item Designation

8

C

Working instruments

C1

Suction and irrigation instruments

8

Suction tube

8.1

Tube

8.2

Luer tube fitting

C2

Rigid cutting instruments

9 10

Item Designation

#

Product no.

Chisel

11

Spoon, distally angled

Chisel, distally angled

#

Product no.

GA--B 235

6.2.2

Forceps and scissors (C3)

12

C3 12.2

12.1

12.3

12.6 12.5 12.7

12.4

#

12.12 12.11

#

0124

12.8

#

12.10 12.9

13 13.2

13.3

13.6 13.5 13.7

13.4

13.1

#

#

0124

13.9

13.8

MXXXXXX

Fig. 4

Legend and identification Item

Designation

Item Designation

C

Working instruments

C3

Forceps and scissors

12

Grasping forceps, unipolar

13

12.1

Jaw

13.1 Jaw

12.2

Jaw insert, not insulated

13.2 Jaw insert, not insulated

12.3

Sheath tube, insulated

13.3 Sheath tube, insulated

12.4

Knurled locking collar

13.4 Knurled locking collar

12.5

Handle (with HF connector and ratchet lock)

13.5 Handle (with HF connector)

12.6

Wheel

13.6 Wheel

12.7

HF connector (unipolar)

13.7 HF connector (unipolar)

12.8

Moveable grip

13.8 Moveable grip

12.9

Locking mechanism (ratcheting)

13.9 Fixed grip

Biopsy forceps, unipolar

12.10 Fixed grip 12.11 Lever 12.12 Trigger

GA--B 235

#

Product no.

9

C3

14 14.7

14.1 14.2 14.3 #

14.6 14.5 14.4

Fig. 5 Legend and identification

6.2.3

Item

Designation

Item Designation

14

Spoon forceps, distally angleable

14.1

Luer--lock cap

14.6 Thrust plate

14.2

Luer connector (for cleaning)

14.7 Jaw

14.3

Locking mechanism

14.4

Deflection lever

14.5

Locking screw

#

Product no.

Product applied in conjunction with motors (C4)

C4

15.1

15.2

15

#

15.3

Fig. 6

Legend and identification Item

Designation

C

Working instruments

C4

Product applied in conjunction with motors

15

Spherical cutter

15.1

Cutter

15.2

External tube

15.3

Drive dog adapter

Item Designation

#

Product no.

For further information see GA--A 202

10

GA--B 235

6.3

Storage system

D

16.1

16.5

16.2

16 16.6

16.3

16.4

Fig. 7

Item

Designation

D

Storage system

16

Item Designation

Reprocessing basket for operating telescope / operating tube

16.1

Basket lid

16.5 Locking mechanism

16.2

Hook

16.6 Holding brackets

16.3

Lower part of basket

16.4

Utensils basket

GA--B 235

#

Product no.

11

Symbols

Meaning Attention, consult ACCOMPANYING DOCUMENTS

REF

Order number Lot identification number

SN

Serial number Manufacturing date Units, pieces (Quantity) Use--by date: Do not reuse (for single use only) Sterilized with ethylene oxide 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).

12

GA--B 235

7

Use WARNING ! Do not reprocess disposable items ! Products marked “disposable“, i.e. for single use only, have been designed for only one use on or in a single patient. If disposable items are reprocessed to be used again, product quality may deteriorate, which will endanger the patient, user and others. In this case, the manufacturer can no longer guarantee the product’s safety and performance. 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.

7.1

Preparation Check assembly: section 9.6 Perform a visual check: section 8 and 8.1

7.2

Diagnosis / therapy -- in the area of the medullary space

7.2.1

Operating telescope

A Inserting operating telescope (2) in operating tube (3) Fig. 8

3 3.2

Insert operating telescope (2) in operating tube (3). Locking the connection: Turn operating telescope (2) to the required position and push in direction of arrow. When the trigger (3.4) is actuated the locking mechanism (3.3) engages automatically. Check for secure connection.

3.4

3.3

NOTE ! Push tab (3.2) as far as it will go and repeat the procedure if the locking mechanism (3.3) won’t engage or if a different position of the operating telescope (2) in the operating tube (3) is necessary or desired.

2

Fig. 8

Attach the complete sealing part (5) Fig. 9

5.1 5.2

3.6 a Fig. 9

GA--B 235

4

Tighten valve insert (4). Tighten screw cap (5.2) with membrane valve (5.1). Install the sealing cap (5.3).

5.3

Irrigation via operating tube (3) Remove the viewing cap (1): see section 7.3.2 Connect the irrigation tube to the irrigation stopcock (3.6). Use a Luer lock tube connector (a) if necessary. Open the irrigation stopcock (3.6). Switch on the irrigation system and check the irrigation flow. Check the entire system for tightness and patency (free passage).

13

Connecting the operating telescope (2) to the system components Fasten the cold light connector (2.11). Connect the fiber light cable via the cold light connector to a suitable light source.

Fig. 10 2.11

2.10

Fig. 10

NOTE ! To obtain optimum light transmission, the diameters of the fiber core of the endoscope and of the fiber light cable must be the same. Possible causes when using a fiber light cable that is too large: the coupling point with the endoscope may become excessively hot is too small: the light output is reduced For a suitable fiber bundle diameter (2.10) please check the product number of the fiber light cable. the code number on the cold--light connector (2.11) must correspond with the two digits to the right of the decimal point of the product number Exception: The fiber light cable 8061.933 has a fiber bundle diameter of 3.5 mm. CAUTION ! Intense heat due to high light energy ! In the case of unfavorable combinations, using the highly temperatureresistant fiber light cable 8063.353 can cause a temperature increase at the coupling point between the fiber light cable and the endosope. The user may get burns and the endocope can become damaged. Reduce the light output, if necessary use fiber light cable with product no. 8061.xxx / 8062.xxx. Perform a functional check: section 8.2 Rinsing / cleaning the objective lens

2.2

The objective lens can be rinsed / cleaned, if required. Fill a disposable syringe with sterile water. Fig. 11 Remove the Luer sealing cap (2.15) from the Luer connector (2.14). Rinsing/cleaning the objective lens (2.2): Connect the disposable syringe to the Luer connector (2.14) and inject sterile water into the irrigation channel.

2.14 2.15 Fig. 11

IMPORTANT ! If you do not need the Luer connector (2.14), make sure it is closed with the Luer sealing cap (2.15). It is not possible to introduce auxiliary instruments through the Luer connector (2.14). NOTE ! Insufflation via Luer connector (2.14) using air is possible, if necessary.

14

GA--B 235

7.2.2

Access instruments

B Establish surgical access / a surgical port. Pre--drill the working sleeve port using a bone drill dia 16.5 mm. Placing obturator (7) in working sleeve (6) Fig. 12 Insert obturator (7) in working sleeve (6). NOTE ! The working sleeve (6) with obturator (7) can also be inserted via the bore (7.1) using an alignment wire (max. dia 2.8 mm).

6

7 7.1

Fig. 12 Carefully screw working sleeve (6) together with obturator (7) into the femur. Remove the obturator (7). Insert the operating telescope (2) with operating tube (3) into the working sleeve (6).

7.2.3

Working instruments

C Insertion of auxiliary instruments The choice of instruments is dictated by the given indication and the surgeon’s requirements. CAUTION ! Danger of injury when inserting the working instruments (C), if the latter are not visible through the scope ! Inadvertent tissue damage is possible. Insert the working instruments (C) only under visual control. Carry out manipulations only if the working instruments (C) are fully visible through the scope, i.e. in the surgeon’s field of view. CAUTION ! Injuries as well as damage to the operating telescope (2) are possible when inserting or retracting forceps and scissors (C3) with open jaw sections ! Inadvertent tissue damage, damage to the distal end of the operating telescope (2) as well as particle loss on the jaw section is possible. Insert and withdraw forceps and scissors (C3) only when the jaw sections are closed and only under visual control. Fig. 13 Insert auxiliary instruments through the working channel (2.4) into the operating area.

2.4

Fig. 13

GA--B 235

15

7.3

Diagnosis and therapy -- in the soft tissue around bones

7.3.1

Operating telescope

A WARNING ! Danger of injury if the operting telescope (2) is inserted without viewing cap (1) ! This may result in unintended tissue damage. Make sure you insert the operating telescope (2) with operating tube (3) only with the viewing cap (1) in place. Installing the viewing cap (1) Fig. 14 Plug the viewing cap (1) onto the distal end of the sheath tube (2.6) and turn until it completely rests against the positioning contour (2.5).

1

Fig. 14

IMPORTANT ! The viewing cap (1) is a sterile disposable item and must therefore only be used once. Discard the viewing cap (1) after use.

2.5 2.6

CAUTION ! Inadvertent loosening of the plug- on viewing cap (1) ! The plug- on viewing cap (1) can loosen from the operating telescope (2) during insertion into the operating field if the operating tube (3) is not used. Use the operating telescope (2) with the plug- on viewing cap (1) only in conjunction with the operating tube (3). Insert the operating telescope (2) with the plug--on viewing cap (1) in place into the operating tube (3): section 7.2.1, Fig. 8 Open up a surgical passage. After previous preparation: Insert the operating telescope (2) with the viewing cap (1) and the operating tube (3) into the operating field. IMPORTANT ! With the plug--on viewing cap (1) in place do not rinse the objective lens (2.2) of the operating telescope (2) and do not irrigate the operating area via the operating tube (3). Removing the operating telescope (2) Fig. 15 To unlock the connection: push tab (3.2) and remove the operating telescope (2). The operating tube (3) remains in the operating area.

3.2 3

2 Fig. 15

16

GA--B 235