Endospike - Suture Passing Instrument 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 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 [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

Intended use...

1

2

Indications and field of use...

1

3

Contraindications...

1

4

Combinations...

1

5 5.1 5.2 5.2.1 5.2.2

Illustration... Legend and identification... Symbols... Suture passing instrument... Needle...

2 2 3 3 3

6 6.1 6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.3

Use... Preparation... Functional description... Inserting the needle cap... Removing the needle cap... Fixing the suture material... Installing/Removing the lever (1.10)... Additional notes and instructions for use...

4 4 4 4 6 6 6 7

7 7.1 7.2

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

8 8 8

8 8.1 8.2 8.3 8.4 8.5 8.6 8.6.1 8.6.2

Reprocessing and maintenance... Disassembly before cleaning... Manual reprocessing... Machine reprocessing... Checks... Assembly before sterilization... Sterilization... Steam sterilization... STERIS and STERRAD sterilization procedures...

9 9 9 10 10 10 10 10 10

9

Technical data and order data... 11

10

Spare parts and accessories... 11

11 11.1

Operating, storage, transport and shipping conditions... 11 Disposal of product, packaging material and accessories... 11

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I

1

Intended use The suture passing instrument serves to intracorporeally pierce suture material e.g. through tissue and pull it through.

2

Indications and field of use In conjunction with endoscopic accessories, this instrument is used in ar­ throscopy. The instrument may be used only by adequately qualified and trained medical personnel.

. 3

NOTE! We recommend reading relevant literature regarding the planned use.

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 On the basis of the patient's general condition the physician / surgeon in charge must decide whether the planned use is possible or not. 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.

4

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 pro­ duct.

1

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5

Illustration 1.6

1.7

1.10

1.5

1.4

1

1.8 1.3

# xxx

xxx

# 1.9

2 2.2

2.3

1.2

1.1

2.1

5.1

Legend and identification Item

Designation

1

Suture passing instrument

Item

Designation

2

Needle

1.1

Grip part 2

2.1

Needle

1.2

Grip part 1

2.2

Needle cap

1.3

Grip part 3

2.3

Spring (for holding the needle)

1.4

Luer connection

1.5

Luer-Lock cap

#

Product no.

1.6

Sheath tube

1.7

Movable jaw section

1.8

Fixed jaw section

1.9

Forceps tube

1.10

Lever

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2

5.2

Symbols

5.2.1

Suture passing instrument Symbols

Designation Caution Follow instructions for use

REF

Order number Lot identification 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).

5.2.2

Needle Symbols

Designation Caution Follow instructions for use

REF

Order number Lot identification number Manufacturing date



Quantity Use--by date: Do not reuse (for single use only) Sterilized using irradiation Keep away from heat <60

< 60 %

25 15

Keep dry, atmospheric humidity < 60 %

Permissible temperature range 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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6

Use WARNING! Do not reprocess disposable items! The service life of products marked "disposable", i.e. for single use only, has been designed for only one use in or on a single patient. If disposable items are reprocessed to be used again, a deterioration of the pro­ duct quality cannot be excluded, endangering the patient, user and third parties. Possible dangers and risk factors are ' strength problems ' damage to the product ' considerable impairment of the product function ' greately increased risk of infection ' biocompatibility problems If a disposable item is reprocessed, the product responsibility lies with the user or reprocessor. In this case the manufacturer can no longer guarantee product safety and per­ formance. 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

1.4 1.5

Z Check assembly: section 8.5 Z Screw luer caps (1.5) onto luer connectors (1.4) (fig. 1). Z Perform a check: sections 7 and 7.1

Fig.1 6.2

Functional description

6.2.1

Inserting the needle cap

Z Close the jaws. ' for this, actuate the grip part (1.3). Z Pull off the forceps tube (1.9) as indicated by the arrow (fig. 2).

1.9

1.3 Fig.2

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4

Z Turn the suture passing instrument through 180_ and install the sterile dispo­ sable needle cap (2.2). ' Place the opening onto the pin (fig. 3).

Fig. 3

. 2.2

NOTE! Before assembly make sure that the needle (2.1) has been inserted into the needle cap (2.2) as far as it will go. (fig. 3a).

2.1 Fig. 3a Z Turn the needle cap (2.2) as indicated by the arrow as far as it will go, i.e. up to the stop (fig. 4). When turning back the needle cap make sure that ' it is held by the pin ' rests correctly against the guides and ' the needle won't slide out of position inside the needle cap.

Fig. 4

2.2

Z After fastening the needle cap (2.2), slide the forceps tube (1.9) in direction of arrow up to the stop (fig. 5). ' The foceps tube engages with a click. ' The forceps jaws must be closed. Actuate the grips (1.3). Z Actuate the forceps once to check the forceps function (fig. 6): ' Close the jaws. For this, actuate the grip part (1.3). ' Push the lever (1.10) upward with your thumb (see fig. 6) 'The grip part (1.1) is unlocked.

Fig. 5

2.2 1.9

' Actuate the unlocked grip part (1.1) with the ball of your thumb - the inserted needle (2.1) is pushed out.

2.1

1.10

1.3

1.1

Fig.6

.

5

NOTE! When releasing the handle (1.1) the needle must be fully retracted. If the needle is not pushed out during the function test, check the position of the needle cap (fig. 4 and fig. 5). Replace the needle cap (2.2) by a spare cap if necessary.

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6.2.2

Removing the needle cap

Fig. 7

Z Remove the forceps tube. Z Swing the needle cap outward as indicated by the arrow. ' see arrow (2.4) on needle cap.

2.1 2.2

.

2.4

6.2.3

After the operation, remove the needle cap together with the needle. For this pro­ ceed in the same order as described under section 6.2.1.

NOTE! When turning the needle cap outward, take into account that the needle is bent as a result of the application and will no longer be completely inside the needle cap. Holding the needle (2.1) in the needle cap (2.2) between your thumb and index finger when turning the needle cap outward will prevent the needle from falling out of the needle cap (fig. 7).

Fixing the suture material

Fig. 8a

1.7

1.8

Z The suture material (y) is fixed distally in the V-shaped groove of the fixed jaw section (1.8), fig. 8a. ' The end of the thread should project approx. 3-4 cm in direction of the mova­ ble jaw section (1.7). Z Fasten the thread to the instrument sheath with your thumb (fig. 8b). ' Slight pulling on the suture material (y) in the direction of the arrow will se­ cure it in the V-shaped groove.

y y

Fig. 8b 6.2.4

Installing/Removing the lever (1.10) The lever (1.10) can be installed on both sides, i.e. for right and left-handed users.. Z Install/remove the lever as shown in fig. 8c.

1.10

Install

Remove

Fig.8c

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6

6.3

Additional notes and instructions for use CAUTION! Danger of injury! Actuate the instrument only under endoscopic or direct view. CAUTION! Danger of injury due to unintentional extension of the needle! Actuate the needle only for the purpose of the function check or during use.

Z Fixation of the suture material in the distal slot of the fixed jaw section. (see section 6.2.3) Z Grasping and positioning of the tissue to be perforated by actuating the grip part (1.3). ' Grasp the tissue in the jaw section firmly before actuating the needle (2.1). Z To unlock the grip part (1.1), push the lever (1.10) upwards with your thumb (see section 6)

.

NOTE ! The locking of grip part (1.1) by lever (1.10) prevents premature triggering of the needle (2.1) i.e. a piercing of the tissue. Z Piercing throught the tissue by actuating the grip part (1.1) using the ball of the hand. ' Actuate the grip part until the suture material is passed through the tissue sufficiently to grasp it easily. ' Fix any tissue grasped with the jaw section in such a way that it won't slide out of place when pierced. ' Make sure that the rigid jaw section (1.8) is pushed against the tissue or rests against the tissue to be pierced when piercing through. Z Pull back the needle by releasing grip part (1.1) The grip part (1.1) is locked again via the lever (1.8). ' For this purpose, keep the jaw section closed. ' A loop of suture material remains on the top surface of the pierced tissue. Z Open the jaw section (1.7). ' The integrated hook of the movable jaw section serves to catch the loop. ' Pulling back the two components pulls the end of the suture material fully through the tissue. Z To manipulate the passed suture material, use the distal toothed area of the jaw section (1.7) or a separate grasping forceps.

7

.

NOTE! If the needle is damaged and won't pierce through the tissue, use a new needle (2).

.

IMPORTANT! Do not use damaged needles.

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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

Fig. 9

IMPORTANT! For sterile products: Contents are sterile providing individual packs are undamaged and have not been opened. ' If the sterile packaging is damaged or the shelf life has expired, don't use the product anymore!

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

CAUTION! Caution if surface in the hinge area of the forceps is damaged!(fig. 9) The hinge pin can loosen. Check for surface changes, such as hairline cracks, around the hinge pin.

7.2

Functional check

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Z Check the grip parts (1.1) (1.2) (1.3) the lever (1.10) and the jaw sections (1.7)(1.8) for easy operation.

8

8

Reprocessing and maintenance WARNING! Creutzfeldt-Jakob Disease! If the patient is suspected of having the Creutzfeldt-Jakob Disease (CJD) or a variant of the Creutzfeldt-Jakob Disease (vCJD) or such a disease has been dia­ gnosed, adequate measures must be taken to prevent a possible transmission to other patients, users and third parties. For this purpose, apply the country-specific reprocessing regulations and gui­ delines. For this purpose, apply the country-specific reprocessing regulations and gui­ delines.

. 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

Z Pull off the forceps tube (1.9). ' Make sure the jaws are closed: see section 6.2.1 Z Remove the needle cap: section 6.2.3. ' discard used needle cap with needle. Z Unscrew luer caps (1.5) (fig. 10). Z Removing the lever (1.10): See section 6.2.4.

1.5

Fig. 10 8.2

Manual reprocessing

Z Wet / dry preparation at the point of use Z Disassembly before cleaning: section 8.1 Z Ultrasound cleaning ' Clean suture passing instrument for 10 min. in ultrasound bath at 40_C with alkaline cleaning agent. Z Manual cleaning / disinfection ' Rinse out the forceps tube and suture passing instrument (via luer connector (1.4)) using the cleaning gun (10 sec permanent or 5 pressure pulses of 3-4 bars)until the liquid running out is clear. ' Clean the jaws, joints, Lever (1.10) and the outside of the forceps tube with a cleaning brush until any visible soiling is removed (fig. 11).

1.4

Fig. 11

9

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8.3

Machine reprocessing

.

IMPORTANT! Rinse out all channels and hollows spaces immediately after use to prevent ope­ ration residues from drying on the instrument. Z Dry preparation at the point of use Z Disassembly before cleaning: section 8.1 Z Pre-cleaning: section 8.2 Z Machine cleaning / disinfection ' Make sure that the suture instrument is rinsed via the luer connectors when cleaned in the washer.

8.4

Checks

8.5

Assembly before sterilization

Z Perform a check: sections 7 and 7.1 Z Plug on the forceps tube (1.9). ' The forceps tube clicks into place. Z Install the lever (1.10)

.

IMPORTANT! Do not screw on the luer cap before sterilization to allow a sufficient flow of the sterilization medium. Screw on the luer cap before use. Z Sparingly lubricate guide (x), hinges (z) and jaw section with instrument oil (fig. 12). ' Actuate the handles (1.1 and 1.3) several times. Z Remove any excess oil.

x

z

1.3

Fig. 12 8.6

Sterilization

8.6.1

Steam sterilization

8.6.2

STERIS and STERRAD sterilization procedures

Z Steam sterilization at 134C (273F) using the fractional pre-vacuum method.

.

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z

1.1

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

10

9

Technical data and order data Illustration

10

Product no.

Designation, technical data

891403000

Suture passing instrument (recommended forceps tube 15570637)

15570637

Forceps tube

Spare parts and accessories Illustration

Product no.

Designation, technical data

491403000

Needle disposable, in sterile packaging, 5/pkg

887.00

Luer sealing cap

886.00

Luer lock tube fitting

86.90

Cleaning brush

6.06

Cleaning brush

200.532

Instrument oil

The products can be combined as required provided the relevant technical data and intended uses are obser­ ved. For the general overview please refer to the latest catalog sheets and brochures, or contact Richard Wolf or your Richard Wolf representative.

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

Disposable items, sterile products

Follow instructions on package !

.

IMPORTANT! Store sterile products in original packaging until they are used. Incorrect storage may lead to loss of sterile properties.

.

NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

11.1

11

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.

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