Ennovate – Spinal System implants

en AESCULAP® Ennovate® Spinal System implants 1.

About this document

Note General risk factors associated with surgical procedures are not described in these instructions for use.

1.1

Scope

These instructions for use apply to Ennovate Spinal System implants. For procedural instructions, please refer to the operating manual. If using additional components, please also refer to their respective instructions for use. ► For article-specific instructions for use as well as information on material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

Note The short summary of safety and clinical performance of the product is available in the European Database for Medical Products (EUDAMED).

2.1

Product description

Additional information on Aesculap implant systems is available from B. Braun/Aesculap or from your local B. Braun/Aesculap agency.

2.1.1

Materials

The materials used in the implant are listed on the packaging: ■ ISOTAN®F titanium forged alloy Ti6Al4V acc. to ISO 5832-3 ■ ISODUR®F wrought cobalt-chromium alloy CoCrMo according to ISO 5832-12 The titanium implants are anodized with a colored oxide layer. Slight changes in coloration may occur, but do not affect the implant quality. ISOTAN® and ISODUR® are trademarks of Aesculap AG, 78532 Tuttlingen / Germany. Products with article number ending in “KS” (e.g. SY450KS) Note The product consists of metal alloys which contain cobalt.

2.2

Areas of use and limitations of use

2.2.1

Intended use

The Ennovate Spinal System implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine.

2.2.2

Indications

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. Use for severe disorders of the spine that cannot be treated by conservative therapies: ■ Fractures ■ Pseudarthrosis or delayed healing ■ Degenerative instability ■ Post-discectomy syndrome ■ Spondylolisthesis ■ Hyper-/hypokyphosis ■ Hyper-/hypolordosis ■ Scoliosis ■ Stenosis ■ Post-trauma instability ■ Tumors ■ Osteoporosis (with the simultaneous use of bone cement and fenestrated screws)

2.2.3

Absolute contraindications

Do not use in the presence of: ■ Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, Paget’s disease, bone tumors etc. ■ Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system ■ Suspected allergy or sensitivity to the implant materials ■ Acute or chronic vertebral infections of a local or systemic nature ■ Poor patient compliance or limited ability to follow medical instructions, particularly in the post-op phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity ■ Cases not listed under indications

2.2.4

Relative contraindications

In the following circumstances, use of the implant system could represent an increased clinical risk and therefore requires precise, individual assessment by the surgeon: ■ Medical or surgical conditions that could negatively impact the success of the implantation, including wound healing disorders ■ Conditions that could subject the spine and implants to excessive pressure; for example, pregnancy, obesity, neuromuscular diseases or disorders ■ Generally poor condition of the patient; for example, drug or alcohol addition In the presence of relative contraindications, the user decides individually regarding the use of the product.

2.3

Risks, adverse effects and interactions

The general risks of surgery are assumed known and are therefore not described in these instructions for use. Potential risks and clinical consequences associated with use of the implant system include, but are not limited to: ■ Implant failure resulting from excessive load: – Warping or bending – Loosening – Breakage ■ Poor stabilization, requiring subsequent revision surgery or surgery to remove the implant system

■ Failed or delayed fusion ■ Infection ■ Fractured vertebral body or bodies ■ Injury of adjacent structures, in particular: – Nerve roots – Spinal cord – Blood vessels – Organs ■ Changes in the physiological curvature of the spine ■ Neurological disorders, including impairment of the gastrointestinal, urological and/or reproductive system ■ Pain or indisposition ■ Bursitis ■ Decreased bone density due to load avoidance ■ Bone atrophy/fracture above or below the treated spine section ■ Limited physical ability ■ Persistence of symptoms that were to be treated by the implantation ■ Paresis ■ Subsequent surgery to remove the implant system ■ Metal/foreign body allergy or hypersensitivity ■ Dural tears ■ Meningitis

2.4

Safety information

2.4.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Always follow the safety advice and information given in the instructions for use. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. Aesculap is not responsible for complications caused by: ■ incorrect indication or implant selection ■ incorrect surgical technique ■ incorrect combination of implant components ■ combination not approved by Aesculap with components from other manufacturers ■ exceeding the limitations of the treatment method or non-observance of essential medical precautions The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

2.4.2

Product

Product-specific safety information WARNING The implant has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. Scanning a patient who has this implant may result in patient injury. In cases of delayed healing, materials fatigue can lead to implant breakage. Implant components can still become bent, broken or loose despite complete bone hardening. The attending physician shall make any decision with regard to the removal of implant components that have been used. Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migration, and other severe complications. Postoperatively, individual patient information, as well as moderate mobility and muscle training is of particular importance. All necessary implant components need to be available and all the instruments, including special Aesculap implant system instruments, need to be present and in working order. ► Do not use instruments made by another manufacturer. Implant all implants of the Ennovate system only with Ennovate instruments. Risk of implant component breakage due to combination with implant components from other manufacturers! ► Only use Aesculap implant components from the Ennovate system. Risk of screw breakage caused by pedicle screws used for spondylolisthesis! ► Support the stabilization measure with an intercorporal fusion (ALIF, PLIF or TLIF). Risk of more complicated revision! ► When using bone cement, use only the fenestrated screws intended for this purpose. ► There is an increased risk of more complicated revision if using fenestrated pedicle screws with a screw diameter greater than 8.5 mm. Risk of implant component loosening due to overloading pedicle screws! ► When using polylocking feature on polyaxial screws, fenestrated polyaxial screws, uniplanar screws, and favored angle screws do not polylock a single pedicle screw more than three times. ► Note further restrictions on the combined implant components in the relevant instructions for use. ► Prior to implantation, check that the implants being used are appropriate for the given anatomy of the patient. ► Do not use implants that are damaged or have already been used. ► Do not use implants to which foreign particles are adhered. ► Do not combine stainless steel implant components with implant components made of titanium as this accelerates the corrosion process in stainless steel, which can lead to implant failure as a result of material fatigue. ► When shaping the rod, avoid scoring or scratching the product and bending it back and forth. Bending the screws will significantly shorten their service life and could cause premature implant failure. Note The implant components have been tested and approved in combination with Aesculap components. If other combinations are used, the responsibility for such action lies with the operating surgeon.

2.4.3

Sterility

Sterile implant components ■ Implant components with article numbers ending in TS (e.g. SY510TS) are individually packed in labeled protective packaging. ■ Implant components with article numbers ending in TS are sterilized by irradiation. The safe sterile provision of the product is only guaranteed if the sterile packaging is undamaged and unopened and the use-by date has not passed. ► Store implant components with article numbers ending in TS in their original packaging. Do not remove them from their original and protective packaging until immediately before implantation. ► Prior to use, visually check the product expiry date and verify the integrity of the sterile packaging. ► Do not use implant components that are past their expiration date or whose packaging is damaged. Damage to implants with article numbers ending in TS caused by reprocessing and resterilization! ► Do not reprocess or resterilize implants with article numbers ending in TS. Non-sterile implant components ■ Implant components with article numbers ending in T (e.g. SY510T) are supplied in an unsterile condition. ■ Implant components with article numbers ending in T are packed individually. ■ Implants delivered in an unsterile condition are delivered clean. ► Follow the sterilization procedure recommended in ISO 8828 for hospitals for all components. ► Store implant components with article numbers ending in T in their original packaging. Do not remove them from their original and protective packaging until immediately before reprocessing. ► Use suitable storage equipment for reprocessing, sterilization and sterile supply. ► Use a suitable tray for cleaning/disinfection, see TA015247. ► Use the system storage device for sterilization and sterile provision. ► Ensure that the implant components in their implant system storage devices do not come into contact with each other or with instruments. ► Ensure that the implant components are not damaged in any way.

2.5

Patient education

The surgical procedure and following information has been explained to the patient, and the patient's consent has been documented: ■ The patient must be informed about possible side effects and interactions of the product with the body, and relevant rules of behavior. ■ The risks of not observing these rules must be explained to the patient. ■ The patient must be informed and educated about the aspects and consequences described in the Side effects and interactions section, and the behaviors associated with these. ■ The patient must undergo regular medical follow-up examinations. ■ Aesculap is not liable for damage in connection with non-observance of the physician's instructions by the patient. ■ The patient must be advised that smoking presents an increased risk of pseudarthrosis and diffuse disc degeneration. The progressive degeneration of adjacent segments as a result of smoking could lead to later clinical failure. ■ The patient must be advised that being overweight places such excessive pressure on the implant that the prospect of failure becomes likely. ■ The patient must be advised that strenuous physical activity in the form of heavy lifting, excessive muscle strain, exaggerated twisting, repeated bending and bending over or running should be avoided until the bones have healed fully. ■ The patient must be instructed to keep pressure off the implant post surgery in order to prevent the onset of clinical problems associated with implant failure.

2.6

Application

2.6.1

Documentation

The user shall devise an operation plan that specifies and accurately documents the following: ■ Selection of the implant components and their dimensions ■ Positioning of the implant components in the bone ■ Location of intraoperative landmarks Each package contains additional labels showing the designation, article and lot number and – if applicable – the individual serial number of the product. ► Use these labels for documentation in the patient’s file (for the hospital). The surgical procedure has been explained to the patient, and the patient’s consent has been documented.

2.6.2

Implantation

Inserting the Ennovate Spinal System screws, hooks, and rods Please refer to the operating manual for the required information about implanting the implant system. Please note the following in particular: ■ All requisite implant components must already be on hand. ■ All the implantation instruments, including the special Aesculap implant system instruments, must be complete and in working order. WARNING Risk of injury to the patient if the pedicle screw is damaged while it is being removed from the packaging! ► When connecting the pedicle screw with the screwdriver SZ262R never brace against the packaging. WARNING Incorrect application can result in trauma to the spinal cord and nerve roots! Severe or fatal hemorrhage as a result of vascular injury! ► Align and insert instruments and implants (i.e. pedicle screws, hooks) under X-ray control or with the aid of a navigation system. ► Take care not to breach the anterior and lateral cortices when screwing in. ► Ensure that the great vessels are not eroded, punctured during implantation or damaged as a result of implant breakage or migration after implantation. ► Take care to avoid pulsatile erosion of the vessels because of close apposition of the implants. ► Ensure that hooks are positioned securely on anatomy. ► Only allow axial load on the screws during screw insertion. Avoid induction of lateral forces during screw

insertion. ► Do not bend metal implants, except for the rods of the Ennovate Spinal Systems. ► Do not bend the rods back or bend them excessively. ► Only use the bending instruments of the Ennovate Spinal System instrument set for bending the rods. ► Use only the cutting instruments from the Ennovate Spinal System instrument set to separate the rods. ► Do not separate the rods at locations which are excessively bent for the cutting instruments. ► Do not create scratches or grooves on the metal implants.

WARNING Inadequate fixation due to incorrect rod position! ► Always position rods with hexagon and tip in such a way that the hexagon or tip is outside the implant head. ► Adjust the curvature of the rod to the anatomical situation. ► Do not bend the rod in the region of the screw head. ► Make certain and check that the screw head is at right angles to the rod. ► Make certain and check that the rod is positioned securely in the groove base.

► To position the set screw, always use the dedicated set screw driver. ► For tightening and loosening the set screw, always use the dedicated screw driver and counter torque. ► Always tighten the set screws, and do so with the dedicated torque wrench handle.

WARNING Risk of injury due to improper mounting of the set screw! ► Position the set screw correctly. ► Make certain that the rods are correctly positioned on the floor of the groove. ► Using the torque wrench handle, tighten the set screw until the torque wrench handle release is audibly triggered. WARNING Implant damage due to overtightening the set screw or insufficient fixation due to undertightening the set screw! ► Check the recalibration/maintenance date on the torque wrench handle maintenance label prior to each use. ► When tightening or loosening the set screws, make certain that the working end of the torque wrench handle shaft 10 N∙m is positioned entirely within the socket of the set screws. ► Apply the torque slowly and without sudden movement until the torque wrench handle release is audibly triggered. ► Use a rigid screw driver to loosen the screw connection. WARNING Implant head expansion caused by tightening the set screw without application of counter torque! ► Always use the counter torque when tightening the set screw. ► If the screw head comes loose during revision of the larger screws (polyaxial screw, polyaxial fenestrated

screw, uniplanar screw, favored angle screw 7.5 mm or larger), remove the remaining screw component with the set screw driver. Inserting the Ennovate Spinal System rod-to-rod connectors/cross connectors Follow the steps below to implant the Ennovate Spinal System rod-to-rod connectors/cross connectors: ► Using the dedicated cross connector holder or rod-to-rod connector inserter, place the rod-to-rod connectors/cross connectors on the rod at the site calculated by the operating surgeon. CAUTION Rod-to-rod connector/cross connector is unusable if set screws are removed or not present! ► Do not unscrew the set screws from the rod-to-rod connector/cross connector. ► Do not swap set screws with other rod-to-rod connector/cross connector components. ► Only use rod-to-rod connectors/cross connectors if all the set screws are present. ► Before tightening the set screws, ensure that the rod-to-rod connector/cross connector is positioned cor-

rectly. WARNING Inadequate fixation due to incorrect rod position! ► Always position the rod-to-rod connector/cross connector in such a way that the rod is completely inserted into the rod-to-rod connector/cross connector. ► Always position rods in such a way that the end of the hexagon and tip of the rod are located outside the clamping area of the rod-to-rod connector/cross connector. ► Always use the dedicated torque wrench shaft 5 N∙m in combination with the dedicated counter torque to

tighten and loosen the set screw. WARNING Risk of injury if rod-to-rod connector is positioned incorrectly! ► Always follow the correct sequence of steps when tightening the set screw. ► Check correct positioning. ► Always tighten the set screws with the dedicated torque wrench handle 5 N∙m. ► With the rod-to-rod connectors open, use the dedicated torque wrench handle 5 N∙m to first tighten the

set screw marked 1 and then the set screw marked 2. WARNING Implant damage due to overtightening the set screw or insufficient fixation due to undertightening the set screw! ► Check the recalibration/maintenance date on the torque wrench handle maintenance label prior to each use. ► When tightening or loosening the set screws, make certain that the working end of the torque wrench handle shaft 5 N∙m is positioned entirely within the socket of the set screws. ► Apply the torque slowly and without sudden movement until the torque wrench handle release is audibly triggered. ► Tighten the set screws with the torque wrench handle 5 N∙m. ► Position the rod-to-rod/cross connector correctly. ► Make certain that the rods are completely inserted into the rod-to-rod/cross connector. ► Make certain that there is no soft tissue caught in the rod-to-rod/cross connector. ► Use a rigid screw driver to loosen the screw connection. ► When tightening or loosening, only subject the set screws to axial pressure. Avoid exerting lateral forces

when tightening or loosening the set screws. Fixing the fenestrated Ennovate Spinal System screws with bone cement To increase anchoring stability, the fenestrated Ennovate screw can be fixed with bone cement. The following must be observed when cementing: Note Do not start cementing until all the screws have been aligned and the rods have been adapted; however, cementing should be completed before locking the fenestrated Ennovate screw! WARNING Implant damage caused by the application of excessive shear forces with the injection cannula! ► Do not subject the injection cannula to transverse loads. ► Do not bend the injection cannula. Note Once the fenestrated Ennovate screw has been cemented, it is no longer possible to change the implant position, use the reduction lever, or make corrections! Note After the fenestrated Ennovate screw has been cemented, explantation of the screw can prove difficult, especially in cases of osteopenia. ► Check the bone cement for proper texture and viscosity before positioning the applier on the injection cannula. Observe the bone cement manufacturer’s instructions! ► Only cement the fenestrated Ennovate screw with a cement suitable for screw augmentation.

WARNING Risk of injury from cement leakage! ► Always apply imaging techniques for control during the preparation and positioning of the implants. ► Make certain that the slots of the fenestrated Ennovate screw are positioned fully inside the bone. ► Take care not to perforate the pedicle cortex. ► Do not penetrate the opposite cortex and ensure that the opposite cortex is undamaged. ► Do not insert or cement the fenestrated Ennovate screw in the fractured or partially resected vertebral body. Carry out preoperative thin-section CT control. ► Insert and screw the injection cannula into the Ennovate screw head without exerting appreciable force. Make certain that the axes of the pedicle screw and the injection cannula are aligned with each other. ► Cement application must always be accompanied by high-quality, image-producing X-ray screening. Use no more than 2 ml of cement for each pedicle screw. WARNING Risk of injury due to material incompatibility! ► Only use application systems that have been approved for use with bone cement. WARNING Contamination of the locking thread/Insufficient fixation when removing the application system due to incorrect viscosity of the cement! ► Make certain the cement has the correct viscosity.

3.5

Manual cleaning/disinfection

3.5.1

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Ultrasonic cleaning

RT (cold)

5

2

D–W

Concentrate, aldehyde-free, phenol-free, pH ~ 9*

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Concentrate, aldehyde-free, phenol-free, pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD–W

-

V

Drying

RT

-

-

-

-

DW: FD–W: RT: *Recommended:

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature BBraun Stabimed

WARNING Wound contamination due to insufficient curing of cement! Risk of set screw thread adhesion, resulting in system instability! ► Observe the correct curing time. ► For monitoring the cement texture, prepare a reference volume of cement together with the cement to be applied. ► Make certain the implant system is not exposed to any load before the cement has reached its final strength.

Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for 5 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Do not clean with brushes or other abrasives that would damage the product surface.

► Wait for the cement to cure completely before removing the injection cannula.

Phase III ► Fully immerse the instrument in the disinfectant solution.

3.

Validated reprocessing procedure

3.1

General safety instructions

Phase IV ► Rinse all accessible product surfaces under running water. ► Drain any remaining water fully.

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 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. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

Single-use products

Damage to implants with article numbers ending in TS caused by reprocessing and resterilization! ► Do not reprocess or resterilize implants with article numbers ending in TS.

3.3

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air). For implant components with article numbers ending in T, which are resterilized, please note the following:

3.6

Mechanical cleaning/disinfection with manual pre-cleaning

Note The cleaning and disinfecting machine 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 machine used for processing must be serviced and checked at regular intervals.

3.6.1

Manual pre-cleaning with ultrasound

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Ultrasound cleaning

RT (cold)

5

2

D–W

Concentrate, aldehyde-free, phenol-free, pH ~ 9*

II

Rinsing

RT (cold)

1

-

D–W

-

Service life

Set screws and rods The biocompatibility and processability was verified by the manufacturer after 500 cycles of repeated processing. The product can be processed up to 500 times with proper care and if it is undamaged and clean. Any additional reuse is the responsibility of the user. Careful visual and functional inspection before each use is the best opportunity to recognize a product that is no longer functional, see Inspection. Pedicle screws The biocompatibility and processability was verified by the manufacturer after 180 cycles of repeated processing. The product can be processed up to 180 times with proper care and if it is undamaged and clean. Any additional reuse is the responsibility of the user. Careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.4

Phase II ► Rinse all accessible product surfaces under running water. ► Drain any remaining water fully.

DW: Drinking water RT: Room temperature *Recommended: BBraun Stabimed Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for 5 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Do not clean with brushes or other abrasives that would damage the product surface. Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.

3.6.2

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

t [min]

Water quality

Chemistry

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

■ Concentrate, alkaline:

Product-specific safety information on the reprocessing method

Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Handle the implants with new gloves only. ► Keep the implant system storage devices/trays covered or closed. ► Process implant system storage devices/trays separately from instrument trays. ► Clean implants must not be cleaned together with contaminated implants. ► Reprocess the implant components individually and separately if no implant system storage devices are available, When doing this, make certain that the implant components are not damaged. ► Mechanically clean and disinfect the implant components. ► Do not reuse surgically contaminated implants. Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood.

– pH ~ 13 – <5 % anionic surfactant

■ working solution 0.5 % – pH ~ 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

DW: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.7

Inspection

► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.7.1

Visual inspection

► Ensure that all soiling has been removed. In particular, pay attention to mating surfaces, hinges, shafts,

recessed areas, drill grooves. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely

scratched and fractured components. ► Check the product for missing or faded labels. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see

Technical service.

3.7.2

Functional test

► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical

service.

3.8

Packaging

► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Make sure that the packaging will prevent a recontamination of the product during storage.

3.9

Steam sterilization

► Validated sterilization process

– Steam sterilization using fractional 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 products 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.

3.10 Storage ► Store sterile packed implant components dust-protected in a dry, dark and temperature-controlled room.

4.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency.

4.1

Service address

Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

5.

Disposal

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA014887

2022-07

Change No. AE0061173