Ennovate mounting system for implants

en ®

Aesculap Ennovate Mounting system for implants Legend

2.3.2

1 Implant mounts DIN 1/1 SZ210R 1a Mounts empty 1b Mounts equipped with inserts 2 Insert for connection rods, straight SZ202R 2a Insert closed 2b Insert equipped and opened 3 Insert for connection rods, bent SZ203R, insertion direction of MIS rods 4 Insert for pedicle screws SZ212R 4a Insert equipped and open 4b Pins for marking the content 4c Diameter legend 5 Insert for locking screws SZ213R The items listed in the legend are only examples. For a complete listing of all available mountings and inserts, see Scope. The depictions in this document are schematic representations only and may deviate from the actual product.

1.

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. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product.

About this document

Product-specific safety information

► In addition to the information in these usage instructions, see also the following documents:

– Usage instructions, trays and metal mounts TA012714 – Usage instructions, Ennovate Spinal System Implants TA014887

2.3.3

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

2.4

Application

WARNING 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 mounts covered or closed. ► Process implant system mounts separately from instrument trays. ► Do not process clean implants together with contaminated instruments. ► Do not reuse surgically contaminated implants.

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

WARNING Risk of gloves getting caught or damaged when handling the implants or trays! ► Always carry out a function test prior to each use of the product.

1.1

► Take note of insertion direction when loading the inserts: the tips of the MIS rods are placed inward, see Fig. 3.

Scope

These directions for use apply to all implant mountings and their inserts: Art. no.

Designation

SZ202R

Ennovate Insert for connection rods, straight

SZ203R

Ennovate Insert for connection rods, bent

SZ210R

Ennovate Mounts of implants DIN

3.

Validated reprocessing procedure

3.1

General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. Note For patients with Creutzfeld-Jakob disease (CJD), suspected CJD, or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products.

SZ211R

Ennovate Mounts of implants 1/2

SZ212R

Ennovate Insert pedicle screws

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

SZ213R

Ennovate Insert locking screws

Note It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this.

► For article specific instructions for use and material compatibility and lifetime information, 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 Shows a possible threat of danger. If not avoided, death or severe injuries may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Product description

The implant mounts are modular. They consist of a tray (SZ210R 1 or SZ211R), which is filled with various inserts. The inserts consist of a bottom part with lid and, as applicable, intermediate levels. They are always placed overhead in the trays. Insert SZ202R 2 receives straight rods up to a length of 200 mm and consists of three levels. Insert SZ203R 3 receives bent rods up to a length of 150 mm and consists of two levels. Insert SZ212R 4 is intended for pedicle screws up to ∅ 7.5, and 60 mm in length. The type and length of the screws in the insert are identified with pins 4b. The diameter is determined with a color legend 4c on the lid. Insert SZ213R 5 receives locking screws. The insert can be inserted upright in all four corners of the trays SZ210R and SZ211R.

2.2

Areas of use and limitations of use

2.2.1

Intended use

Ennovate mounts and their inserts are used for holding and storing Ennovate implants during cleaning and sterilization, as well as during transport.

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. Indications are described in the corresponding instructions for use of Ennovate implant TA014887.

2.2.3

Absolute contraindications

Note For the latest information on reprocessing and material compatibility see also the B. Braun eIFU at eifu.bbraun.com

3.2

General notes

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 6 hours should pass between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non 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 damage to the products in case of non stainless steel. These must be removed by rinsing thoroughly with desalinated water and then drying. Perform 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 reprocessing the product. All of the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Visual changes in materials, e.g., fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be 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 surface and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, section Publications, Red Brochure – Proper preparation of instruments.

3.3

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best option to determine if a product is no longer functional, see Inspection.

3.4

Preparation at the place of use

► If applicable, rinse surfaces that are not accessible for visible inspection (preferably with highly purified water),

for instance using a disposable syringe. ► Remove any visible surgical residues as much as possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container and forward it on for cleaning and disinfection within 6 hours.

Absolute contraindications are described in the corresponding instructions for use Ennovate Implants TA014887.

3.5

Cleaning/Disinfection

2.2.4

3.5.1

Product-specific safety information on the reprocessing method

Relative contraindications

Relative contraindications are described in the corresponding instructions for use of Ennovate Implants TA014887.

2.3

Safety information

2.3.1

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. ► Follow the safety and maintenance instructions. ► 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. ► Prior to use, check that the product is in good working order. ► 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.

Direct or indirect contamination may render implants unsuitable for resterilization! ► Do not reprocess implants that have been directly or indirectly contaminated with blood. Risk of infection from unwashed areas! ► Ensure correct insertion direction of implants in the inserts. ► Alway place inserts overhead in tray. Risk of infection! ► During automated pre-cleaning and manual cleaning: place inserts in ultrasound bath without tray. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents which – are approved for plastic material and high-grade steel, – do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of in a wet condition. To prevent foaming and

degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water.

3.6

Manual cleaning/disinfection

3.8.1

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution.

Visual inspection

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

areas, drill grooves and the sides of the teeth on rasps.

► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

► 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

3.6.1

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Ultrasound cleaning

RT (cold)

>5

1

D–W

B. Braun Cleaner N

► Check the product for missing or faded labels (such as handle colors, gold layers). ► 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 Tech-

scratched and fractured components.

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

B. Braun Stabimed

IV

Final rinse

RT (cold)

1

-

FD–W

-

V

Drying

D–W: FD–W: RT:

RT

-

-

-

-

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

nical service.

3.8.2

Functional test

► Check that the product functions correctly. ► Check the product for the function of the opening and closing mechanism between the basket and the cover. ► Check that all moving parts are working property (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.

3.9

Packaging

► Package trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

3.10 Steam sterilization ► 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

Phase I ► Place inserts in ultrasound bath without tray. ► Clean the product in an ultrasound cleaning bath (frequency of 35 kHz) for at least 5 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Drain any remaining water fully. Phase III ► Fully immerse the instrument in the disinfectant solution. Phase IV ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phaser with a lint-free cloth or medical compressed air.

3.7

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.

3.7.1

Manual pre-cleaning with ultrasound

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Ultrasound cleaning

RT (cold)

>5

1

D–W

B. Braun Cleaner N

– 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 ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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

4.

Maintenance and Service

4.1

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. Service addresses 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.

4.2

Spare parts

Art. no.

Designation

TF279P

Identification pin "X" for screw/rod

TF280P

Identification pin "25" for screw length in SZ212R

TF281P

Identification pin "30" for screw length in SZ212R

TF282P

Identification pin "35" for screw length in SZ212R

TF283P

Identification pin "40" for screw length in SZ212R

TF284P

Identification pin "45" for screw length in SZ212R

TF285P

Identification pin "50" for screw length in SZ212R

Phase II ► Rinse/flush the instrument thoroughly (all accessible surfaces) under running water.

TF286P

Identification pin "55" for screw length in SZ212R

3.7.2

TF287P

Identification pin "60" for screw length in SZ212R

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed Phase I ► Place inserts in ultrasound bath without tray. ► Clean the product in an ultrasound cleaning bath (frequency of 35 kHz) for at least 5 minutes. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided.

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: – 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

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alkaline ► Place tray equipped with inserts in the cleaning and disinfecting machine. ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

3.8

Inspection

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

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. TA015247

2019-12

V6

Change No. 61047