BBraun

ABC E Plate Instruments

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File Name: BBraun - AESCULAP - TA011800 2017-12 Change No. 58 - ABC E Plate Instruments - 2018-01 - 00.pdf

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C G A

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Aesculap® ABC E Plate Instruments

Legend A B C D E F G H I Y K L M N

ABC E Plate Instruments Aesculap®

ABC distraction clamp FJ888R ABC plate bender FJ826R ABC end pin for adaptation and removal forceps FJ892R ABC adaptation forceps FJ885R ABC insert for adaptation forceps caudal FJ887R ABC insert for adaptation forceps cranial FJ886R ABC single insert for adaptation forceps FJ891R ABC explantation screwdriver FJ837R ABC E plate bit, conical, FJ847R ABC removal foreceps FJ889R CASPAR elevator FF917R ABC plate holding forceps FJ890R ABC single drill guide for central plate hole FJ884R ABC drill FJ840R

Intended use The instruments named in the instructions manual are used for the implantation of the ABE E plate for anterior cervical fusion. The instruments of the ABC system are required in addition. They enable the surgeon to adapt ABC implants individually for each patient and to position and insert the implant. The ABC E plate instruments consist mainly of stainless instrument steel according to ISO 7153-1.

Safe handling and preparation CAUTION Federal law restricts this device to sale by, or on order of a physician!

WARNING

Symbols on product and packages Sterilization using irradiation Not for reuse in intended applications as defined by the manufacturer Use by

Caution, general warning symbol Caution, see documentation supplied with the product Date of manufacture

Applicable to ► For item-specific instructions for use and information on material

compatibility, see also www.extranet.bbraun.com

the

Aesculap

Extranet

Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

The operating surgeon must be thoroughly conversant with stabilization techniques for, and the biomechanical properties of, the cervical spine. He must be familiar both theoretically and practically with the operation technique of the ABC system and of the ABC E plate. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Observe the instructions for use for the ABC E plate (TA011799), the ABC plates and screws (TA009693), the ABC instruments (TA009777) and the ABC explantation instruments (TA011500), as well as the operating manuals for the ABC E plate (brochure no. O27102) and the ABC system (brochure no. O17702). ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).

DANGER

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product.

Art. no.

Designation

FJ847R

ABC E plate bit (conical)

The product is gamma-sterilized and supplied in sterile packaging. The product must not be reused. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

2 1 Fig. 1 ► For a better view of the operation field: Fold down the distraction

clamp A (max. 90°), see Fig. 2. ► Insert CASPAR distraction pin into the adjacent vertebral body accord-

ing to the standard technique, see operating manual O15902. Ideally, the pin is perpendicular to the posterior cortex of the vertebral body. ► Push the CASPAR distractor 3 (FF901R/FF891R) into the sleeve 2 of the distraction clamp A and over the adjacent distraction pin. ► Distract according to the requirements. As soon as the annulus is opened, the distraction instrument restore the normal lordosis.

Safe operation

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Applying the distraction clamp Since the already implanted ABC plate is not removed and thus no distraction pin can be set in the bone on this side, the distraction clamp A replaces the customary CASPAR distraction pin here.

CAUTION

Fig. 2

Damage of the ABC plate and of the distraction clamp by incorrect application of the distraction clamp! ► Apply the distraction clamp always only in the bending zone of the ABC plate. ► Always guide the claw of the distraction clamp under the ABC plate.

► Apply the distraction clamp A in the bending zone of

the already implanted ABC plate 1, so that the sleeve 2 points in direction of the vertebral body to be fused, see Fig. 1 and see Fig. 2.

Aesculap® ABC E Plate Instruments

Prepare affected intervertebral disc spaces The affected intervertebral disc spaces are prepared in the usual way. This usually means: removal of the intervertebral disc decompression of the spinal canal and the neural foramina by removal of bone or soft tissue that are narrowing this area, and finally the shaping of the intervertebral disc space after appropriate preparation of the endplate. If necessary,this can be carried out with the aid of a corporectomy. Subsequently, the E plate is inserted as described (starting from the section Loosening screws on the ABC plate) in the following sections.

H H

Loosening screws on the ABC plate To be able to adapt the ABC E plate to the ABC plate, the two screws of the ABC plate located closest to the affected intervertebral disc cavity must be loosened.

CAUTION

Risk of the ABC E plate bit breaking and damage to the ABC screw caused by overtorquing or lateral bending with the screwdriver! Risk of the ABC E plate bit breaking and/or damage to the ABC screw if the ABC E plate bit is not fully inserted into the screw head! ► Always insert the ABC E plate bit fully into the screw head. ► Avoid strong, abrupt movements with the screw driver. ► Always replace loosened ABC screws with new ABC screws. Risk of damage to the ABC screw and ABC plate if the straight explantation bit (FJ848R) with the white marking is used in first step! ► Always use the conical ABC E plate bit I (FJ847R) in first step. ► Carry out the other explantation steps before using the straight explantation bit (FJ848R), see instructions for the ABC explantation instruments TA011500.

I I Fig. 3 ► Insert ABC E plate bit I fully into the head of ABC screw 2 and unlock

locking pin 1 of the ABC screw. ► Firmly press on the screwdriver with your hand; at the same time turn the screwdriver counter-clockwise with gradually increased torque, until the screw is released from the bone. ► Completely unscrew ABC screw. Note Do not in any way reuse unscrewed ABC screws. ► If the ABC screw cannot be removed and the conical ABC E plate bit I

(black marking) is broken off, carry out explantation steps, see instructions for the ABC explantation instruments TA011500.

► Remove adhering tissue from the ABC screw.

► Insert conical ABC E plate bit I (black marking) into ABC explantation

screwdriver H.

3 2

Fig. 4 4

I 1

Preparing the ABC plate ► Remove adhering tissue at the side of the ABC plate at which the ABC

E plate should be adapted. Use cautery and soft tissue instruments such as small periosteum elevators for this purpose. ► Clean the bottom of the ABC plate with the CASPAR elevator K at the adaptation place of the ABC E plate.

4 B

Adapting the ABC E plate Note Only the bisegmental ABC E plates have bending zones. These plates can be adapted to the anatomical circumstances with the ABC plate bender. Monosegmental ABC E plates are pre-bent to the optimum cervical lordosis angle and can not be further adjusted.

WARNING

Damage to the ABC E plate and fracture caused by excessive bending! ► Never bend the monosegmental ABC E plate. ► Bend bisegmental ABC E plates only inside the bending zone. ► Bend the bisegmental ABC E plate longitudinally and within the bending zone only. ► Do not bend bisegmental ABC E plate back.

► Remove osteophytes from anterior vertebral surface before adjusting

Fig. 5

Inserting and positioning the ABC E plate

CAUTION

the ABC E plate. ► If a bisegmental ABC E plate should be used, check whether this must

be bent in addition. ► Always use plate bender B (FJ826R) to bend the bisegmental ABC E

plate. ► Avoid small bending radii, bending back, notching, or scratching of the

ABC E-Plate. ► To reinforce the lordosis: – Place the ABC E plate 4 with the bending zone centrally between the two upper rollers of the plate bender B. – Press handle parts together until the desired degree of bend is achieved.

Risk of damage to the ABC E plate, the ABC plate and the adaptation forceps D due to incorrect implant assembly! ► Use only a light blue cranial ABC E plate on the cranial side of the ABC plate. ► Use only a gold coloured caudal ABC E plate on the caudal side of the ABC plate.

► verify that

– the ABC E plate is of suitable length – only a light blue cranial ABC E plate is used on the cranial side of the ABC plate – only a gold coloured caudal ABC E plate is used on the caudal side of the ABC plate. ► Prior to positioning the ABC plate, verify that the UP arrow points in cranial direction. ► Use plate holding forceps L to grasp any two opposite plate holes of ABC D plate. ► Compress the handles of the plate holding forceps to activate the lock. The plate holder holds the ABC E plate independently. ► Place ABC E plate 4 at the desired height, as close as possible to the existing ABC plate.

Aesculap® ABC E Plate Instruments

► Align the center lines of the ABC plate and of the ABC E plate to one

► When implanting a gold coloured caudal ABC E plate: Push the caudal

another. ► Once the ABC E plate is correctly positioned, press the handles of the plate holder L further together to release the lock.

insert E with yellow colour ring) up to the stop into the other end of the adaptation forceps D. - or ► Instead of the caudal insert E or the cranial insert F use a single insert G.

L D

4 C Fig. 7

Fig. 6

► Insert ABC adaption forceps D with caudal insert E or cranial insert F

Adapting and fixing the ABC E plate to the ABC plate

CAUTION

► Push the end pin C up to the stop into the corresponding end of the

ABC adaptation forceps D, see Fig. 7 ► When implanting a light blue cranial ABC E plate: Push the cranial insert F (with light blue colour ring) up to the stop into the other end of the adaptation forceps D, see Fig. 7. - or -

E/F/G

into the plate holes of the ABC E plate 4, which are next to the adaption claw, see Fig. 8. - or ► When using single insert G, insert adaptation forceps D with single insert G into the pin hole located closest to the adaptation claw. ► Insert adaption forceps D with end pin C into the pin hole of the already implanted ABC plate 1, which is closest to the ABC E-Plate 4 that is to be implanted, see Fig. 8.

D 1 4

D Fig. 9

E/F/G

4 1

Fig. 8

CAUTION

WARNING

Damage of the ABC E plate due to slanted application to/pushing onto the ABC E plate! ► Align the center lines of the ABC plate and of the ABC E plate to one another before pushing together. ► Align the angles of the ABC plate and of the ABC E plate to one another in all levels before pushing together. Failure to achieve the wanted stabilization properties due to incomplete pushing of the ABC E plate onto the ABC plate! ► Push the ABC E-Plate completely onto the ABC plate.

► Push the ABC E plate carefully onto the ABC plate by pressing the han-

dles of the adaptation forceps D together. ► If necessary slightly correct the position of the ABC E plate when push-

ing it on. Make sure that – the center lines of the ABC plate and of the ABC E plate are aligned to one another – the angles of the ABC plate and of the ABC E plate are aligned to one another in all planes. ► Make sure that ABC E plate 4 and ABC plate 1 are completely pressed together, see Fig. 9.

WARNING

Not achieving the wanted stabilization properties due to loose or damaged ABC screws or due to damaged screw holes in the vertebral body! ► Insert new screws into the drill holes of the ABC plate before setting the screws on the ABC E plate. ► Never reuse loosened or completely removed ABC screws. Always replace loosened or completely removed ABC screws with new ABC screws. ► In the case of a damaged screw hole in the vertebral body, replace the ABC screw by an ABC revision screw (pink).

Lock 5 on the ABC adaption forceps D (see Fig. 7 and see Fig. 8) prevents the ABC E Plate from sliding back on the ABC plate after insertion. So that the ABC E plate does not shift after the lock is released, a temporary fixation pin (FJ833RS) can be inserted into a pin hole of the ABC E plate with the aid of the pin insertion and withdrawal instrument FJ835R. ► Optional: Before opening the lock 5, insert a temporary fixation pin (FJ833RS) into a pin hole of the ABC E plate on the ABC adaptation forceps D, see instructions for the fixation pins (TA009932) and instructions for the ABC instruments (TA009977). ► Release the lock on the adaptation forceps D: Press the handles together lightly and at the same time press on the locking lever 5, see Fig. 7 and see Fig. 9. ► Remove the adaptation forceps D from the plates

Aesculap® ABC E Plate Instruments

Preparing the central drill hole (optional) Note Preparing the central drill hole is possible only for the golden caudal ABC E plates and is recommended at the thoracic transition for additional stability. The central screw can be set on the ABC E plate at other segments of the cervical spine optionally at the discretion of the surgeon.

The holes for the ABC screws are drilled with the drill N and using the single drill guide M. The drill holes can be drilled manually with the drill handle FJ839R or with a motor system and an Aesculap Intra handpiece (e.g. DG 450M/GD456M). The central plate hole of the ABC E plate is inclined by 30°. Otherwise is corresponds to the other plate holes. Using the rotatable foot plate 7 of the single drill guide M the screw insertion angle can be varied by 30° +/– 20° in caudocranial direction, see Fig. 11. An angle of +/– 6° is possible in addition in medio-lateral direction. Note The optimum angle can be defined under fluoroscopic control.

DANGER

WARNING

CAUTION

Risk of drilling into the patient’s spinal cord as a result of the cutting depth set incorrectly on the single drill guide! ► Insert the ABC drill into the drill guide and check the set cutting depth with a calliper (e.g. AA845R).

6 6 7 4 Fig. 10 The single drill guide M for the central plate hole is depth adjustable, see Fig. 10. ► Insert the drill N into the single drill guide M and check with vernier calliper. ► To set the wanted cutting depth, turn the guide sleeve 6 of the single drill guide M in the + or – direction, see Fig. 10. Note that the thread of drill guide is of the left-handed type. Every half turn (= height adjustment by 0.5mm) you will hear and feel the guide sleeve clicking into position.

Incorrect cutting depth and damage through repointed or shortened drills! ► Never repoint the ABC drill. ► Any blunt drill must be replaced by a new one.

7 4

Defective drill hole of damage of ABC E plate and ABC screw due to drilling with wrong or without drill guide! ► Always drill the central drill hole with ABC single drill guide (FJ884R). Fig. 11

► Observe the instructions for use of the ABC drill (TA009931).

CAUTION

Risk of tension between the ABC E plate and screws if the screws are set in the wrong order! ► The center screw on the ABC E plate should be set before any other screws.

CAUTION

Risk of damage to the ABC E plate and to the ABC screws by angulating the single drill guide beyond the stop at the foot plate! ► Never angulate the single drill guide beyond the stop. ► Always angulate the single drill guide only in a range from 10° to 50° in cranial direction vertically in relation to the ABC E plate.

Setting ABC screws on the ABC E plate Use off-the-shelf technology to prepare drill holes for ABC screws as well as to insert and lock screws as described in detail in the instructions for use of the ABC instruments (TA009777). Note the differences in setting the screws on the ABC E plate, as described below. Positioning the ABC screws in the elongated holes of the ABC E plates differs slightly from recommended positioning of the ABC screws in the standard ABC plate.

► Insert the rotary foot plate 7 of the single drill guide M into the central

plate hole of ABC E plate 4 for drilling. ► Align the rotatable tip 7 of the single drill guide M so that it is aligned with its thick side to the thick side of the ABC E plate, see Fig. 11. ► Insert the drill guide into the E plate with light pressure. ► Drill to a safe cutting depth. To reduce the risk of injuring the patient's spinal cord when drilling, increase cutting depth gradually, as needed, under fluoroscopic control. Thread cutting as well as inserting and locking of ABC screws is described in detail in the instructions for use of the ABC instruments (TA009777).

CAUTION

Damage of the ABC E plate, of the ABC revision screw as well as of the screwdriver due to insertion of a revision screw (pink) in the central plate hole! ► Never use a revision screw for the central plate hole of a caudal ABC E plate.

► Set ABC screw into the central plate hole of the ABC E plate and lock

it, see instructions for use of the ABC instruments TA009777.

Fig. 12 ► To guarantee the dynamics of the system and optimum settling of the

screws, position the screws in the ABC E plate as follows, see Fig. 12: – Screws in the farthest distally located plate holes always as far as possible distally. – Screws with a long bisegmental ABC E plate in the central plate holes centrally, unless the vertebral anatomy requires a different positioning (see Fig. 12, figure on the left). – Screws with a short bisegmental ABC E plate in the central, relatively short plate holes as far distally as possible in order to achieve the best possible settling (see Fig. 12, figure on the right).

Removing the fixation pin ► Observe the instructions for use of the fixation pin FJ833RS

(TA009932). ► Remove temporary fixation pins FJ833RS with pin insertion and pin

withdrawal instrument FJ835R.

Aesculap® ABC E Plate Instruments

Disassembling

Removing the ABC E plate Always use ABC instruments to remove ABC implants. This section describes how the ABC E plate can be removed without removing the ABC plate. In order to unlock and remove the ABC screws, observe the instructions in the operating manual of the ABC system in addition to the following instructions. ► Unlock and loosen the screws on the ABC plate located closest to the ABC E plate using the explantation screwdriver H, see Loosening screws on the ABC plate. ► Unlock and remove the screws on the ABC E plate, see the operating manual of the ABC system (brochure no. O17702).

Adaptation forceps FJ885R

5 D

J E

1 C

E/F/G

Fig. 14 ► Withdraw the insert E, F or G against the direction of the arrow.

Fig. 13 ► In each case push the end pin C up to the stop into the two ends of the

removal forceps J, see Fig. 13.

CAUTION

Risk of damage to the ABC E plate, the ABC plate and the ABC removal forceps J due to incomplete insertion of the end pins (FJ892R) into the adjacent pin holes of the ABC plate and the ABC E plate! ► Ensure that end pins C are completely seated in the pin holes of the ABC plate and the ABC E plate.

► Insert the tips of the end pins C completely into the adjacent pin holes

of the ABC plate 1 and of the ABC E plate 4, see Fig. 13. ► Press the handles of the ABC removal forceps J together carefully until

the ABC E plate 4 separates from the ABC plate 1.

► Withdraw the end pin C against the direction of the arrow. If the end

pin C cannot be withdrawn by hand, withdraw it with a small pair of pliers without hard metal inserts. Removing broken off insert or end pin: ► If one of the inserts or the end pin is broken off due to overload, press out the reminder with the aid of a 2 mm wire from the back through the inclined bore.

Assembling

Drill guide FJ884R

Adaptation forceps FJ885R

► Insert bit E, F or G and end pin C all the way in in the direction of the

arrow, see Fig. 14.

Drill guide FJ884R

► Attach guide sleeve 6 by turning it anticlockwise. Be aware that it is a

left-handed thread, see Fig. 15.

Removal forceps FJ889R ► Insert end pins C in the direction of the arrow until it engages, see

Fig. 16.

Fig. 15 ► Remove guide sleeve 6 by turning it clockwise. Be aware that it is a

left-handed thread. You will hear and feel the guide sleeve clicking into position every half turn.

Removal forceps FJ889R

C Fig. 16 ► Withdraw the end pins C against the direction of the arrow If one of

the end pins C cannot be withdrawn by hand, withdraw it with a small pair of pliers without hard metal inserts. Removing a broken off end pin: ► If one of the end pins is broken off due to overload, press out the reminder with the aid of a 2 mm wire from the back through the inclined bore.

Aesculap® ABC E Plate Instruments

Validated reprocessing procedure General safety instructions Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Single-use products

WARNING

Art. no.

Designation

FJ847R

ABC E plate bit (conical)

General information Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as described in the

respective instructions for use. ► Open up instruments with hinges.

Preparations at the place of use ► If applicable, rinse non-visible surfaces preferably with deionized

► Carry out ultrasound cleaning:

– as an effective mechanical supplement to manual cleaning/disinfection. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfection. – as an integrated mechanical support measure for mechanical cleaning/disinfection. – for additional cleaning of products with residues left after mechanical cleaning/disinfection.

water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

disinfection within 6 hours.

Preparation before cleaning ► Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which – are approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum permitted cleaning temperature of 60 °C. Hazard caused by inadequate cleaning, disinfection and sterilization! ► Always clean explantation screwdriver FJ837R FJ837R with ultrasound prior to manual or mechanical cleaning.

► Use suitable cleaning/disinfecting agents if the product is put away in

a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

Aesculap® ABC E Plate Instruments

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Manual cleaning with immersion disinfection

Chapter Manual cleaning/disinfection and sub■ Cleaning brush: e.g. FF494801 for FJ885R and FJ889R chapter: ■ 20 ml disposable syringe ■ Chapter Manual cleaning with immersion ■ Keep working ends open for cleaning. disinfection ■ When cleaning instruments with movable hinges, ensure that these

■ FJ884R ■ FJ885R ■ FJ886R ■ FJ887R ■ FJ889R ■ FJ890R ■ FJ891R ■ FJ892R Mechanical alkaline cleaning and thermal disinfection

are in an open position and, if applicable, move the joint while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air

■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ FJ826R ■ FJ840R ■ FJ886R ■ FJ887R ■ FJ890R ■ FJ891R ■ FJ892R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ FJ884R ■ FJ885R ■ FJ888R ■ FJ889R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FJ837R

Reference

Chapter Mechanical cleaning/disinfecting and sub-chapter:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Chapter Mechanical cleaning/disinfection with ■ Cleaning brush: e.g. FF494801 for FJ885R and FJ889R manual pre-cleaning and sub-chapter: ■ 20 ml disposable syringe ■ Chapter Manual pre-cleaning with a brush ■ Place the instrument in a tray that is suitable for cleaning (avoiding ■ Chapter Mechanical alkaline cleaning and rinsing blind spots). thermal disinfecting

■ 20 ml disposable syringe ■ Place the instrument in a tray that is suitable for cleaning (avoiding rinsing blind spots).

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Manual cleaning/disinfection ► Prior to manual disinfecting, allow water to drip off for a sufficient

length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for

residues. ► Repeat the cleaning /disinfection process if necessary.

Manual cleaning with immersion disinfection Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Disinfecting cleaning

RT (cold)

>15

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Intermediate rinse

RT (cold)

D–W

III

Disinfection

RT (cold)

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Final rinse

RT (cold)

FD-W

Drying

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15

min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until

all discernible residues have been removed from the surface.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.

► If applicable, brush through non-visible surfaces with an appropriate

Phase IV

cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.

► Rinse/flush the product thoroughly (all accessible surfaces).

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.

► Mobilize non-rigid components, such as set screws, joints, etc. during

final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure.

Aesculap® ABC E Plate Instruments

Mechanical cleaning/disinfecting Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical/Note

Prerinse

<25/77

D–W

Cleaning

55/131

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

FD-W

Thermal disinfecting

90/194

FD-W

Drying

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

Mechanical cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883).

Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Disinfectant cleaning

RT (cold)

>15

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Rinsing

RT (cold)

D–W

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

► Mobilize non-rigid components, such as set screws, links, etc. during

syringes, see Validated cleaning and disinfection procedure.

cleaning. ► Thoroughly rinse through these components with the cleaning disin-

Phase I

fectant solution (at least five times), using a disposable syringe.

► Fully immerse the product in the cleaning/disinfectant for at least 15

Phase II

min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until

► Rinse/flush the product thoroughly (all accessible surfaces) under run-

all discernible residues have been removed from the surface.

ning water.

► If applicable, brush through non-visible surfaces with an appropriate

► Mobilize non-rigid components, such as set screws, joints, etc. during

cleaning brush for at least 1 min.

rinsing.

Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Ultrasonic cleaning

RT (cold)

>15

D–W

Aldehyde-free, phenol-free, and QUAT-free concentrate, pH ~ 9*

Rinsing

RT (cold)

D–W

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I

► Mobilize non-rigid components, such as set screws, links, etc. during

cleaning. ► Thoroughly rinse through these components with the cleaning disin-

fectant solution (at least five times), using a disposable syringe.

► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for

at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

Aesculap® ABC E Plate Instruments

Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

Prerinse

<25/77

D–W

Cleaning

55/131

FD-W

■ Concentrate, alkaline: – pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

FD-W

Thermal disinfecting

90/194

FD-W

Drying

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

► Appropriately protect products with fine working tips.

Inspection, maintenance and checks

CAUTION

Damage (metal seizure/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature. ► After each complete cleaning, disinfecting and drying cycle, check that

the instrument is dry, clean, operational, and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products. Note Intensive use of the instruments leads to normal wear. 18

Packaging ► Store products with ratchet locks fully opened or locked no further

than in the first notch. ► Close the locks so that the jaw tips just touch each other. ► Place the product in its holder or on a suitable tray. Ensure that all cut-

ting edges are protected. ► Pack trays appropriately for the intended sterilization process (e.g. in

sterile Aesculap containers). ► Ensure that the packaging provides sufficient protection against

recontamination of the product during storage.

Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► Check to ensure that the sterilizing agent will come into contact with

all external and internal surfaces (e.g. by opening any valves and faucets).

► Validated sterilization process

Technical Service

– Disassemble the instrument – Steam sterilization through fractionated vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min ► When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

Risk of injury and/or malfunction! ► Do not modify the product. WARNING ► For service and repairs, please contact your national B. Braun/Aesculap

agency. Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. Service addresses

Sterilization for the US market

■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.

■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave. To achieve a sterility assurance level of 10-6, Aesculap recommends the following parameters: Aesculap Orga Tray/Sterile container (perforated bottom) Minimum cycle parameters* Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles may also be suitable, however individuals or hospitals not using the recommended method are advised to validate any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility after processing, such as a wrap, pouch, etc. WARNING for the US market If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of crosscontamination.

Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 (7461) 95-1602 Fax: +49 (7461) 16-5621 E-Mail: [email protected] Or in the US: Aesculap Implant Systems LLC Attn. Aesculap Technical Services 615 Lambert Pointe Drive Hazelwood MO, 63042 Aesculap Repair Hotline Phone: +1 (800) 214-3392 Fax: +1 (314) 895-4420 Other service addresses can be obtained from the address indicated above.

Distributor in the US/Contact in Canada for product information and complaints Aesculap Implant Systems LLC 3773 Corporate Parkway Center Valley, PA, 18034, USA

Storage ► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area. ► Store sterile packed single-use products dust-protected in a dry, dark

and temperature-controlled room.

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