DOC576, Rev. B-ABC2 Brochure

Aesculap®

Aesculap Spine

Instructions for use/Technical description

A-Space SIBD and ArcadiusXP L Instruments

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Aesculap® A-Space SIBD and ArcadiusXP L Instruments

Aesculap®A-Space SIBD and ArcadiusXP L Instruments

Legend 1 Packing Block (SJ604R)2 Tamp (SJ608R)3 T-Handle (SJ033R)4 Handle (FW440R)5 Ratchet Handle (SJ705R)6 Slap Hammer Handle (SJ708T)7 Slap Hammer Extension (SJ709R)8 Implant Introducer (SJ605R)*9 Trial Insertion Instrument (ME020R)10 Implant Inserter Manipulator (ME015R)11 U-Joint Screwdriver (ME014R)12 Straight Ball Hex Screwdriver (ME013R)13 Straight Hex Screwdriver (ME016R)14 Flexible Screw Driver (SJ706R)15 Torque Limiting Handle (ME012R)16 Flexible Bone Awl (SJ607R)17 Straight Bone Awl (ME017R)18 Straight Drill (SJ725R)19 Flexible Drill (SJ723R)20 Straight Drill Guide (SJ724R)21 Angled Drill Guide (SJ722R)22 Impactor (SJ606R)23 Implant Extraction Instrument (ME018R)24 Trial Implant (SJ664T – SJ798T: 36 sizes)25 Distractor 10 mm–20 mm (SJ020R, SJ022R,

SJ024R, SJ026R, SJ028R, SJ030R)* Instrument offered upon customer request only, notincluded in the instrument set.

Symbols on product and packages

Applicable to� A-Space SIBD and ArcadiusXP L� For item-specific instructions for use and informa-

tion on material compatibility, see also theAesculap Extranet at www.extranet.bbraun.com

Intended useThe A-Space SIBD and ArcadiusXP L Instruments areused for the implantation of A-Space SIBD andArcadiusXP L devices into the lumbar spine. Indicationsand contraindications are listed in the instructions foruse for the implants (TA013175 and TA015555).

Caution, general warning symbolCaution, see documentation sup-plied with the product

3

Safe handling and preparationCAUTION

Federal law restricts this device to sale by, or on

order of a physician!

� Always follow the instructions for use of the A-Space SIBD and ArcadiusXP L implants (TA013175and TA015555) and the respective surgical tech-niques.

� Ensure that the product and its accessories areoperated and used only by persons with the requi-site 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.� Remove the transport packaging and clean the new

product, either manually or mechanically, prior toits 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 compo-nents.

� Do not use the product if it is damaged or defec-tive. Set aside the product if it is damaged.

� Replace any damaged components immediatelywith original spare parts.

Safe operation

Distraction

� Desired distraction of the vertebral bodies can beachieved by using the Distractors (SJ020R -SJ030R).

� Desired working height can be gradually achievedby coupling a Distractor to a T-Handle (SJ033R),inserting horizontally into the disc space androtating by 90°.

WARNING

Risk of injury and/or product

malfunction!

� Always carry out a func-

tion check prior to using

the product.

WARNING

Risk of damage to the spinal

cord, spinal nerve roots, adja-

cent intervertebral bodies or

soft tissue when inserting and

using the Distractor!

� Do not over insert the Dis-

tractor into the disc space.

� Do not over distract the

disc space.

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Selection of Implant Size Using Trial

Implants

� Attach selected Trial Implant to the Trial InsertionInstrument (ME020R) by inserting the Instrumentinto the anterior face of the Trial Implant. Turn thewheel clockwise to engage the Trial Implant ontothe Trial Insertion Instrument.

� To advance the Trial Implant into the disc space useeither a mallet or a Slap Hammer Extension(SJ709R) assembled onto a Slap Hammer Handle(SJ708T).

� Under lateral and anterior-posterior fluoroscopyconfirm the:– Implant depth, height, and lordosis– Endplate coverage (anterior-posterior / medial-

lateral)– Midline placement– Implant rotation

� Select the implant size that corresponds with thefinal Trial Implant size chosen.

Filling the Implant

� Fill the implant with bone or bone replacementmaterial by using the Packing Block (SJ604R) andTamp (SJ608R).

WARNING

Risk of over distracting, dam-

aging the endplates, or adja-

cent vertebral bodies in the

course of incorrectly applying

the Trial Insertion Instrument!

� During the Trial Implant

insertion, do not apply an

excessive bending/tilting/

levering force to the Trial

Insertion Instrument

(ME020R).

� Keep the instrument

directly in the plane of the

disc.

WARNING

If the Trial implant is inserted

too deep there is a risk of

damage to the spinal cord, spi-

nal nerve roots, posterior

structures!

� Always use the Trial Inser-

tion Instrument (ME020R)

with a depth stop.

� Do not apply excessive

hammering force.

WARNING

Risk of selecting incorrect

implant size!

� Fluoroscopy is mandatory

to confirm the final Trial

Implant size.

� Trial Implant must provide

good contact with the

inferior and superior end-

plates. Therefore the

proper footprint, height,

and lordotic angle should

be chosen for the disc

space.

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Implant Placement and Positioning

� Securely attach the implant (corresponding to thefinal Trial Implant size) to the distal end of theinsertion instrument by turning the wheel clock-wise.

The laser markings (CRANIAL/CAUDAL) on the implantinsertion instrument indicate the correct orientationfor implant engagement.:� The Implant Inserter/Manipulator (ME015R) will

grip the implant utilizing the two lateral implantscrew holes.

� The Implant Introducer (SJ605R) will grip theimplant utilizing the two medial implant screwholes.

� Use appropriate care when inserting the implant.– Drive the Implant into the disc space using

either a mallet or the Slap Hammer Extension(SJ709R) assembled onto the Slap HammerHandle (SJ708T).

� Confirm an anatomically suitable position and ori-entation of the implant. It is recommended to con-firm implant position prior to removing the implantinserter.– Obtain an AP fluoroscopic image to confirm

midline placement of the device.– Obtain a lateral fluoroscopic image to confirm

that the anterior edge of the implant is seatedflush with the anterior border of the vertebralbody.

– Observe the X-Ray markers in both the AP andlateral views to ensure that the implant is notrotated within the disc space.

� Use Impactor (SJ606R) to adjust the position (in APdirection) of the implant as necessary.

Bone Screw Placement

� Use the bone awls (Straight Bone Awl (ME017R) orFlexible Bone Awl (SJ607R)) and the drills (StraightDrill (SJ725R) or Flexible Drill (SJ723R)) to preparea pilot hole for the bone screws at the intendedscrew placement site.

WARNING

Inaccurate marking of the

midline may result in incorrect

positioning of the implant!

� Always mark the midline

under X-ray visualization.

� Determine the center of

the vertebral disc using the

midline marker, under X-

Ray visualization.

WARNING

If the implant is inserted too

deep, the spinal canal and

other posterior elements may

be compressed!

� Always use the Implant

Inserter/Manipulator

(ME015R) with a depth

stop.

� Excessive hammering may

over-insert implant.

WARNING

Risk of damaging biological

structures (spinal cord, spinal

nerve roots, ligaments, vessels,

soft tissues, etc.) with the

drills and the bone awls, espe-

cially if the PEEK cage is

placed off midline!

� The instruments are sharp,

always use the bone awls/

drills under X-Ray control.

6


� Always use the Drills and Straight Bone Awl withthe drill guides (Straight Drill Guide (SJ724R) orAngled Drill Guide (SJ722R)).

� Attach bone screw of appropriate length to theselected self-retaining screwdriver (Straight HexScrewdriver (ME016R), Straight Ball Hex Screw-driver (ME013R), Flexible Screw Driver (SJ706R),and U-Joint Screwdriver (ME014R)).

� Place a bone screw through selected screw hole onthe anterior face of the implant.

WARNING


structures (spinal nerve roots,

ligaments, vessels, soft tissues,

etc.) upon disengaging the

flexible instruments!

� The working end of the

Flexible Bone Awl

(SJ607R) may elastically

spring back to the original

shape upon disengagement

from the Implant and the

working end of the Flexible

Drill (SJ723R) may elasti-

cally spring back to the

original shape upon disen-

gagement from the Angled

Drill Guide (SJ722R).

� Follow Surgical technique,

or training by Aesculap.

WARNING




soft tissues, etc.) due to

Straight Bone Awl tip or

Straight Drill tip breaking!

� Do not apply an excessive

bending/tilting/levering

force to the Straight Bone

Awl (ME017R) or Straight

Drill (SJ725R).

WARNING

Risk of damaging PEEK cage

with incorrectly applied

Straight Drill Guide (SJ724R)!



force to the instrument.

WARNING

Engaging the screwdriver

incorrectly when turning the

bone screw into the PEEK cage

may result in damage to the

bone screws!

� Fully insert the tip of the

screwdriver into the bone

screw.

WARNING




soft tissues, etc.) while

advancing incorrectly sized

bone screws, especially if the

PEEK cage is placed off mid-

line!

� Always advance the bone

screws, especially the

diverging lateral screws,

under X-Ray control.



WARNING

Applying too much torque may

result in damage to the bone

screws and the PEEK cages!

� Use of the Torque Limiting

Handle (ME012R) is rec-

ommended.

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� Turn the screwdriver in a clockwise motion toadvance the bone screw into the vertebral body.

� Insert the bone screws until they reach the finalseated position, ensuring full engagement of thetwo locking mechanisms.

� Repeat the bone screw placement steps outlinedabove to insert the remaining bone screws throughthe implant.

Revision

� Locate implant, which is to be revised, and engageselected self-retaining screwdriver (Straight HexScrewdriver (ME016R), Straight Ball Hex Screw-driver (ME013R), Flexible Screw Driver (SJ706R), orU-Joint Screwdriver (ME014R)) in the bone screwhead.

� Retract the bone screw from the vertebral body byturning the screw in a counterclockwise motion.

� Repeat the bone screw removal process with theremaining bone screws in the PEEK cage.

� Engage Implant Extraction Instrument (ME018R)or the Implant Inserter/Manipulator (ME015R) tothe implant and remove it from the disc space.

NoteIf a fully seated bone screw is removed from theimplant, a small piece of PEEK debris from the lockingrim in the locking mechanism may be present.

WARNING

Risk of damage to the PEEK

cage, or the bone screw head

in the course of incorrectly

driving the bone screw!



force to the Straight Hex

Screwdriver (ME016R) or

Straight Ball Hex Screw-

driver (ME013R) engaged

in the bone screw.

� Keep the screwdrivers

directly aligned with the

axis of the bone screws.

WARNING

The screws could back out or

loosen if they are not fully

inserted into the cage!

� Insert the bone screw until

it is fully engaged.



WARNING

Risk of insufficient stability or

implant failure if fewer than

four screws are used!

� Apply all four screws or use

an additional supplemental

spinal fixation system such

as the Aesculap S4 Spinal

System.

WARNING

Risk of injury to the patient!

� Remove implant in the

direction it was inserted.

� Excessive force during

extraction may cause

implant to dislodge sud-

denly and impact the sur-

rounding tissues.

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General

� Caution should be taken while operating theinstruments with quick connect modular handles:T-Handle (SJ033R), Handle (FW440R), RatchetHandle (SJ705R), Slap Hammer Handle (SJ708T)and Torque Limiting Handle (ME012R).

� Caution should be taken for assembling the follow-ing modular instruments: Implant Inserter/Manip-ulator (ME015R), Implant Introducer (SJ605R),Flexible Drill (SJ723R), Straight Hex Screwdriver(ME016R) and Straight Ball Hex Screwdriver(ME013R).

Disassembling

Straight Ball Hex Screwdriver (ME013R)

and Straight Hex Screwdriver (ME016R)

� Unthread the nut 30 from the distal end of theshaft.

� Remove the screwdriver bit 31 from the shaft.� Remove the soft tissue protection sleeve 32 from

the shaft, see Fig. 1.

Fig. 1 Disassembling ME013R and ME016R

WARNING

Activating the "PRESS" button

on the handle while actively

using the instruments can

result in the instrument shaft

detaching from the handle!

� Do not cover the "PRESS"

button with hand when

utilizing fully assembled

instruments.

WARNING

Risk of not being able to

securely engage implant or

damaging the instrument with

incorrectly assembled Implant


(ME015R) or Introducer

(SJ605R)!

� Ensure that the instru-

ments are correctly assem-

bled prior to the surgery.

WARNING

Danger from improperly

assembled Flexible Drill

(SJ723R): the flexible drill bit

may disengage from the

instrument shaft!

� Prior to the surgery, ensure

that the drill bit is secured

to the instrument shaft by

firmly tightening the nut

until it is fully threaded.

WARNING


assembled Straight Hex


Straight Ball Hex Screwdriver

(ME013R): the screwdriver bit


instrument shaft!

� Prior to surgery, ensure

that the screwdriver bit is

secured to the instrument

shaft, by firmly tightening

the nut until it is fully

threaded.

3130

32

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U-joint screwdriver (ME014R) and

Implant Extraction Instrument (ME018R)

� Remove the spring 33 covering the u-joint fromthe distal end of the shaft, see Fig. 2 and see Fig. 3.

Fig. 2 Disassembling ME014R


Flexible Drill (SJ723R)

� Unthread the nut 34 from the distal end of theshaft.

� Remove the drill bit 35 from the shaft end, see Fig.4.

Fig. 4 Disassembling SJ723R

Implant Inserter Manipulator (ME015R)

and Implant Introducer (SJ605R)

� While holding the proximal end (mechanism withthumb wheel) upright, unthread the nut 36 coun-terclockwise towards the proximal end.

� With the nut disengaged from its threading, turnthe thumb wheel 37 clockwise ("LOCK" - direction)until the sub-assembly 38 disengages from theouter sheath 39.

� Pull out the sub-assembly 38 from the outersheath 39.

� Remove the depth stopper 40 by pushing it distallyparallel along the shaft until it disengages from its

33

33

3435

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rail, see Fig. 5 and see Fig. 6.


Fig. 6 Disassembling SJ605R

Trial Insertion Instrument (ME020R)

� Press the locking mechanism button 41 near thethumb wheel and pull out the outer sheath 42.

� Remove the inner shaft 43 from the thumb wheel.� Remove the depth stopper 44 by pushing it distally

parallel along the shaft until it disengages from itsrail.


36

38

3840

39

37

36

38

3840

39

37

43

42

41

44

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Assembling

Straight Ball Hex Screwdriver (ME013R)

and Straight Hex Screwdriver (ME016R)

� Place the soft tissue protection sleeve 32 over theinner shaft.

� Insert the screwdriver bit 31 into the internalhexagon of the distal end of the shaft.

� Firmly thread the nut 30 proximally over thescrewdriver bit until it is fully threaded, see Fig. 8.

Fig. 8 Assembling ME013R and ME016R

U-joint screwdriver (ME014R) and

Implant Extraction Instrument (ME018R)

� Slide the spring 33 over the distal end until it iscompletely covering the u-joint, see Fig. 9 and seeFig. 10. The ends of the spring should sit within theflange on the shaft and the flange on the distalhead, see Fig. 11.

Fig. 9 Assembling ME014R


Fig. 11 Correct spring position

WARNING


assembled Straight Hex


Straight Ball Hex Screwdriver

(ME013R): the screwdriver bit


instrument shaft during ship-

ment or operation!

� Ensure the screwdriver

bit 31 is secured to the


the nut 32 until it is fully

threaded

32

31

30

33

33

12


Flexible Drill (SJ723R)

� Insert the drill bit 35 into the internal hexagon ofthe distal end of the shaft.

� Firmly thread the nut 34 over the drill bit towardsthe proximal end until it is fully threaded, see Fig.12.

Fig. 12 Assembling SJ723R

Implant Inserter Manipulator (ME015R)

and Implant Introducer (SJ605R)

� Place the depth stopper 40 on its rail and press itproximally along the shaft until it is fully engaged.

� Insert the sub-assembly 38 all the way into theouter sheath 39.

� Start turning the thumb wheel 37 counterclock-wise ("RELEASE"-direction) while pressing the sub-assembly towards the thumb wheel.The threads between the end of the sub-assemblyshaft and the inner thread in the thumb wheel willstart to engage.

� Continue turning the thumb wheel until the pro-trusions of the sub-assembly are flush with theslots in the outer sheath.

� Visually verify that both components (38 and 39)are fully engaged, see Fig. 15.

WARNING


assembled Flexible Drill

(SJ723R): the flexible drill bit


instrument shaft during ship-

ment or operation!

� Ensure that the drill bit 35

is secured to instrument


the nut 34 until it is fully

threaded.

3435

WARNING

Risk of not being able to

securely engage the implant or

damaging the instrument with

incorrectly assembled Implant


(ME015R) or Introducer

(SJ605R)!

� Ensure that there is no gap

between components 38

and 39.

� Firmly tighten the nut 36

until it is fully threaded.

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� Firmly thread the nut 36 towards the distal enduntil it is fully threaded, see Fig. 13 and see Fig. 14.


Fig. 14 Assembling SJ605R

Fig. 15 Correct engagement of sub-assembly andouter sheath

Trial Insertion Instrument (ME020R)

� Place the depth stop 44 on its rail and press itproximally along the shaft until it is fully engaged.

� Insert the hexagonal end of the inner shaft 43 intothe inner hexagon of the thumb wheel 45.

� Place the outer sheath 42 over the inner shaft 43.� Press the locking mechanism button 41 and fully

insert the outer sheath into the locking mechanism(until it reaches the hard stop).

� Release the button 41, see Fig. 16.


40

38

38

39

37

36

36

4038

38

39

37

t = 0

39383938

t > 0

43

42

45

4441

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Validated reprocessing procedure

Disassembling the product before carry-

ing out the reprocessing procedure

� Disassemble the product immediately after use, seeDisassembling.

Preparation before cleaning

� Dismantle the product prior to cleaning, see Disas-sembling.

Cleaning/disinfection

Product-specific safety notes on the repro-

cessing procedure

� Use suitable cleaning/disinfecting agents if theproduct is put away in a wet condition. To preventfoam formation and reduced effectiveness of theprocess chemicals: Prior to mechanical cleaningand disinfection, rinse the product thoroughly withrunning water.

� Carry out ultrasound cleaning:– as an effective mechanical supplement to man-

ual cleaning/disinfecting.– as a pre-cleaning procedure for products with

encrusted residues, in preparation for mechan-ical cleaning/disinfecting.

– as an integrated mechanical support measurefor mechanical cleaning/disinfecting.

– for additional cleaning of products with resi-dues left after mechanical cleaning/disinfect-ing.

DANGER

Risk to patients!

� The Ratchet Handle

(SJ705R), Slap Hammer

Handle (SJ708T), Slap

Hammer Extension

(SJ709R), Torque Limiting

Handle (ME012R), Implant

Inserter Manipulator

(ME015R), Implant Intro-

ducer (SJ605R), Straight

Drill Guide (SJ724R), and

Trial Insertion Instrument

(ME020R) must only be

cleaned mechanically.

CAUTION

Damage to the product due to

inappropriate cleaning/disin-

fecting agents and/or exces-

sive temperatures!

� Use cleaning and disinfect-

ing agents according to the

manufacturer’s instruc-

tions which are approved

for high-grade steel.

� Observe specifications

regarding concentration,

temperature and exposure

time.

15

Validated cleaning and disinfection procedure

NoteReprocessing may only take place in accordance with the following listed procedures in version V6. These are doc-umented in the Validated Reprocessing Procedures brochure (AVA-V6). You can also find this brochure in theAesculap extranet at www.extranet.bbraun.com

Validated procedure Specific requirements Reference

Manual cleaning with immersion disinfection� ME013R

� ME014R

� ME016R

� ME018R

� SJ604R

� SJ606R

� SJ607R

� SJ608R

� SJ722R

� SJ723R

� SJ725R

� SJ020R – SJ030R (6 sizes)

� SJ664T – SJ798T (36 sizes)

� Cleaning brush: e.g. TA011944, TE654202, GK469200

� Disposable syringe 20 ml

� When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

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

Chapter Manual cleaning/disinfection and sub-chapter:� Chapter Manual cleaning with

immersion disinfection

Manual cleaning with ultrasound and immer-sion disinfection� SJ706R



� When cleaning products with movable hinges, ensure that these are in an open position and, if applicable, move the joint while cleaning.

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

Chapter Manual cleaning/disinfection and sub-chapter:� Chapter Manual cleaning with

ultrasound and immersion disinfection

16


Mechanical alkaline cleaning and thermal disinfection� FW440R

� SJ033R

� SJ604R

� SJ606R

� SJ608R

� SJ725R

� SJ020R – SJ030R (6 sizes)

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

� Place products in the tray with their hinges open.

Chapter Mechanical cleaning/disinfecting and sub-chapter:� Chapter Mechanical alkaline cleaning

and thermal disinfecting

Manual pre-cleaning with brush and subse-quent mechanical alka-line cleaning and ther-mal disinfection� ME012R

� ME013R

� ME014R

� ME016R

� ME018R

� SJ607R

� SJ705R

� SJ708T

� SJ722R

� SJ723R

� SJ664T – SJ798T (36 sizes)





Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chap-ter:� Chapter Manual pre-cleaning with a

brush

� Chapter Mechanical alkaline cleaning and thermal disinfecting


17

Inspection, maintenance and checks

� Allow the product to cool down to room tempera-ture.

� After each complete cleaning, disinfecting and dry-ing cycle, check that the product is dry, clean,operational, and free of damage (e.g. broken insu-lation 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 Ser-vice, see Technical Service.

� Assemble dismountable products, see Assembling.� Check for compatibility with associated products.

Packaging

� Appropriately protect products with fine workingtips for the following instruments: SJ607R,ME017R, SJ723R, SJ725R, SJ706R, ME013R,ME014R and ME016R.

� Place the product in its holder or on a suitable tray.Ensure that all cutting edges are protected.

� Pack trays appropriately for the intended steriliza-tion process (e.g. in Aesculap sterile containers).

� Ensure that the packaging provides sufficient pro-tection against recontamination of the productduring storage.

Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection� ME015R

� SJ605R

� ME020R

� SJ706R

� SJ709R

� SJ724R





Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chap-ter:� Chapter Manual pre-cleaning with

ultrasound and brush

� Chapter Mechanical alkaline cleaning and thermal disinfecting


CAUTION

Damage (metal seizure/fric-

tion corrosion) to the product

caused by insufficient lubrica-

tion!

� Prior to function checks,

lubricate moving parts (e.g.

joints, pusher components

and threaded rods) at the

marked lubrication points,

using maintenance oil suit-

able for the respective

sterilization process (e.g.

for steam sterilization:

Aesculap STERILIT® I oil

spray JG600 or STERILIT® I

drip lubricator JG598).

18


Steam sterilization

NoteThe product can be sterilized either in disassembled orin assembled condition.

� Check to ensure that the sterilizing agent will comeinto contact with all external and internal surfaces(e.g. by opening any valves and faucets).

� Validated sterilization process– Steam sterilization through fractionated vac-

uum process– Steam sterilizer according to DIN EN 285 and

validated according to DIN EN ISO 17665– Sterilization using fractionated vacuum pro-

cess at 134 °C/holding time 5 min� When sterilizing several products at the same time

in a steam sterilizer, ensure that the maximum loadcapacity of the steam sterilizer specified by themanufacturer is not exceeded.

Sterilization for the US market

� Aesculap advises against sterilizing the device byflash sterilization or chemical sterilization.

� Sterilization may be accomplished by a standardprevacuum cycle in a steam autoclave.

To achieve a sterility assurance level of 10-6, Aesculaprecommends the following parameters:

*Aesculap has validated the above sterilization cycleand has the data on file. The validation was accom-plished in an Aesculap sterile container cleared by FDA

for the sterilization and storage of these products.Other sterilization cycles may also be suitable, how-ever individuals or hospitals not using the recom-mended method are advised to validate any alternativemethod using appropriate laboratory techniques. Usean FDA cleared accessory to maintain sterility afterprocessing, such as a wrap, pouch, etc.WARNING for the US market

If this device is/was used in a patient with, or sus-

pected of having Creutzfeldt-Jakob Disease (CJD),

the device cannot be reused and must be destroyed

due to the inability to reprocess or sterilize to elim-

inate the risk of crosscontamination.

Storage

� Store sterile products in germ-proof packaging,protected from dust, in a dry, dark, temperature-controlled area.

Aesculap Orga Tray/Sterile container (perforated

bottom)

Minimum cycle parameters*

Steriliza-

tion method

Temp. Time Minimum

drying

time

Prevacuum 270 °F/275 °F

4 min 30 min

19

Technical Service

� For service and repairs, please contact yournational B. Braun/Aesculap agency.

Modifications carried out on medical technical equip-ment may result in loss of guarantee/warranty rightsand forfeiture of applicable licenses.

Service addresses

Aesculap Technischer ServiceAm Aesculap-Platz 78532 Tuttlingen / GermanyPhone: +49 (7461) 95-1602Fax: +49 (7461) 16-5621E-Mail: [email protected] 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) 895-4420Other service addresses can be obtained from theaddress indicated above.

Disposal� Adhere to national regulations when disposing of

or recycling the product, its components and itspackaging!

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

WARNING

Risk of injury and/or malfunc-

tion!

� Do not modify the product.

- DIR 93/42/EEC Technical alterations reserved

Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | GermanyPhone +49 (0) 7461 95-0 | Fax +49 (0) 7461 95-26 00 | www.aesculap.com

Aesculap – a B. Braun company TA-Nr. 015556 08/12 V6

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DOC576, Rev. B-ABC2 Brochure

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