Ennovate ratcheting and torque handles

2.3.2

en ®

Aesculap Ennovate Ratcheting and torque handles Legend 1 2 3 4 5 a b c d

Ennovate ratcheting handle, straight, medium SZ222R Ennovate T-ratcheting handle SZ224R Ennovate ratcheting handle, drop-shaped SZ225R Ennovate torque handle 10 Nm SZ228R Ennovate torque handle 10 Nm SZ229R Sliding sleeve Sliding ring Instrument shaft Dial

The depictions in this document are schematic representations only and may deviate from the actual product.

1.

About this document

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

Product

Product specific safety information ► Please note usage instructions for Ennovate instruments TA014986/TA014987/TA014988, Ennovate implants TA014887, and operating manual O00702/O48102. ► Do not use the product on active or motorized drive systems. ► Observe permitted product operating temperature of 10 °C to 40 °C., ► Only use Aesculap instruments and accessories. ► Hints on inserting the instruments into the supports: Observe the graphic/packing template.

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 Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. Note The ratcheting handle is black. The torque handle is purple.

2.4.1

Coupling the handle

Art. no.

Designation

SZ222R

Ennovate ratcheting handle, straight, medium

SZ224R

Ennovate T-ratcheting handle

For handles with a black PEEK sliding sleeve: ► Insert instrument shaft c with compatible hexagonal coupling all the way into the sliding sleeve a of the handle, see Fig. A. ► Check that the instrument is secure seated. For handles with sliding ring: ► Retract sliding ring b to open the lock, see Fig. C. ► Insert instrument shaft c with compatible ¼" coupling all the way into the sliding sleeve b of the handle. ► Let go of sliding ring b. ► Check the instrument for secure seat.

SZ225R

Ennovate ratcheting handle, drop-shaped

2.4.2

SZ228R

Ennovate torque handle, 10 Nm

SZ229R

Ennovate torque handle 5 Nm

1.1

Scope

These instructions for use apply for the following products:

Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► 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 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

2.1

Product description

A hexagonal coupling is used to couple Ennovate ratcheting handles to Ennovate instrument shafts in order to simplify the use of this instrument by providing an improved grip and operating torque. Ennovate torque handles are used to limit the torque to a set value. The 10 Nm Ennovate torque handle is coupled to the inserting instrument for the locking screw, the alignment instrument, or the PolyBlocker using a hexagonal coupling to apply a rated torque of 10 Nm to the locking screw., The 5 Nm Ennovate torque handle is coupled to the inserting instrument for connectors using a ¼" coupling to apply a nominal torque of 5 Nm to the connector.,

2.2

Areas of use and limitations of use

2.2.1

Intended use

The Ennovate instruments are used for the implantation of Ennovate Spinal System implants.

2.2.2

Indications

Ratcheting handles: Adjust ring ratchet

► Set dial d to one of the three following positions, see Fig. E:

– Label "IN": Clockwise rotation, tighten instrument – Center position "∙": Lock handle (ratcheting function is inactive) – Label "OUT”: Counter-clockwise rotation, unscrew instrument

2.4.3

Torque handles: Trigger torque

Note The specified torque only applies in case of a clockwise rotation (direction of arrow). ► Only use the torque handles in combination with counterholder. ► Rotate torque handle clockwise until the acoustic signal of the triggering torque handle is heard.

The acoustic signal indicates that the torque has been reached.

2.4.4

Uncoupling the handle

► Retract sliding ring/sliding sleeve a/b to open the lock, see Fig. B/D. ► Pull instrument c out of handle.

3.

Validated reprocessing procedure

3.1

General safety instructions

Note Observe national statutory regulations, national and international standards and directives, and any proprietary hygiene instructions for processing. Note For patients suffering from Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the processing of products. Note Machine processing should be favored over manual cleaning as it gives better and more reliable results. Note Please note that successful processing of this medical device can only be guaranteed once the processing method has been validated. The operator/processor shall be responsible. The recommended chemical was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used.

Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

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.

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

3.2

2.2.3

Dried and hardened or clotted surgical residues can complicate cleaning or render it ineffective and cause corrosion. Therefore, do not exceed a period of 6 hours between use and processing, make sure pre-cleaning temperatures are >45 °C to avoid clotting, and do not use disinfectants that can cause clotting (active ingredient basis: aldehyde, alcohol). Using too much neutralizing agent or basic cleaners may cause chemical corrosion and/or fading, and laser markings on stainless steel may become unreadable, either visually or for the machine. For stainless steel, residues containing chlorine or chloride (such as surgical residues, drugs, saline solutions in water for cleaning purposes, disinfection and sterilization) may cause corrosion (pitting corrosion, stress corrosion) and eventually the destruction of the product. To remove such residues, rinse thoroughly using demineralized water, then dry. Additional drying, if necessary. Only use process chemicals that have been tested and approved (e.g. VAH or FDA approval, or have a CE mark) and are recommended by the manufacturer of the chemicals as being compatible with the materials. Strictly adhere to any and all directions for use from the manufacturer of the chemicals. Failure to do so can result in the problems listed below: ■ Optical deterioration, e.g. fading or discoloration of titanium or aluminum surfaces. In the case of aluminum, a pH value > 8 of the make-up solution/working solution suffices 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 as they can cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKI-Brochures", "Red brochure".

Absolute contraindications

Absolute contraindications are described in the instructions for use of Ennovate implants TA014887.

2.2.4

Relative contraindications

Relative contraindications are described in the 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. 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.

3.3

General advice

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 visible, preferably using demineralized water – for instance from dispos-

able syringes. ► Remove any visible surgical residues as thoroughly as possible using a damp, lint-free cloth. ► Place the dry product in a sealed waste container within 6 hours to be taken for cleaning and disinfecting.

3.5

Cleaning/Disinfection

3.7.1

Manual pre-cleaning using immersion disinfection, ultrasound and brush

3.5.1

Product-specific safety information on the reprocessing method

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Immersion cleaning

Cold

5

-

D–W

-

II

Brushes

Cold

-

-

D–W

-

III

Intermediate rinse

Cold

-

-

D–W

-

IV

Ultrasound cleaning

40/104

>5

0.5

D–W

B. Braun Helimatic® Cleaner alkaline*

V

Rinse

RT (cold)

1

-

D–W

-

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning agents and disinfectants according to the manufacturer's instructions, – which are approved for plastics and high-grade steel, – that 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. ► For wet disposal, use suitable cleaning agents/disinfectants. To avoid foam formation and reduced effectiveness

of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly under running water

3.5.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Manual cleaning with ultrasound and immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Move moving parts during cleaning. ■ Drying phase: Use a lint-free cloth or medical compressed air ■ Phase IV: Rinse lumens using spray nozzle (3.8 bar water pressure) at least 3 times for 20 seconds each.

Manual pre-cleaning using immersion disinfection, ultrasound and brush, and subsequent machine alkaline cleaning and thermal disinfection

■ Suitable cleaning brush ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ Phase II: Rinse lumens using spray nozzle (3.8 bar water pressure) at least 3 times for 20 seconds each.

■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

3.6

D–W: RT: *

Drinking water Room temperature Validated using Dr. Weigert Hamburg neodisher® MediClean

► Observe information on suitable cleaning brushes and disposable syringes, see Validated cleaning and disinfec-

tion procedure. Phase I ► Fully immerse the product in cold water for 5 min. Ensure that all accessible surfaces are wetted. Phase II ► Clean all surfaces, gaps and lumens using a soft cleaning brush (Medisafe MED 100.43) and a bottle brush (Medisafe MED 100.25) under running water until no residue is visible. ► Move non-rigid components, such as adjusting screws, joints, etc., during rinsing. Phase III ► Rinse any surfaces that are not visible, gaps and lumens each at least 5 times using a pressurized water gun and a pressure of at least 3.8 bar. Phase IV ► Clean the product in an ultrasound cleaning bath for at least 5 minutes. Make sure that all accessible surfaces are wetted and sonic shadows are avoided. ► Move non-rigid components, such as adjusting screws, joints, etc., during cleaning.

Manual cleaning/disinfection

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

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

Phase V ► Rinse any surfaces that are not visible, gaps and lumens each at least 5 times using a pressurized water gun and a pressure of at least 3.8 bar.

3.7.2

Alkaline machine cleaning and thermal disinfection

3.6.1

Manual cleaning with ultrasound and immersion disinfection

Type of device: Miele G7735 CD

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

Phase

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

III

Disinfection

RT (cold)

1

RT (cold)

5

-

2

D–W

D–W

Step

T [°C/°F]

I

Pre-rinse

Cold

2

D–W

-

II

Cleaning

55/131

5

DI–W

B. Braun Helimatic® Cleaner alkaline*

III

Intermediate rinse

Cold

3

DI–W

-

IV

Final rinse

Cold

2

DI–W

-

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

V

Thermal disinfection

93/200

5

DI–W

-

Drying

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

V

Drying

RT

-

-

-

-

D–W: DI-W:

D–W: FD–W:

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

*

infection procedure. Phase I ► 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. ► 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. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. 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 five times at the beginning of the exposure time with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► 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.

3.7

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.

Water quality

Chemical/Comment

In accordance with the program for the cleaning and disinfection device

Drinking water Deionized water (demineralized, microbiological at least in compliance with potable water regulations) Validated using Dr. Weigert Hamburg neodisher® MediClean

► Check visible surfaces for residue after machine cleaning/disinfection.

3.8 ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

t [min]

Inspection

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

3.8.1

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. ► 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 product for missing or faded labels and/or paint marks (e.g. color of handle, gold plating). ► 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.

3.8.2

Functional test

CAUTION The product may be damaged (metal pitting/fretting corrosion) if insufficiently oiled! ► Oil any moving parts (e.g. joints, spool parts and threaded rods) prior to the functional test using oil suitable for the applied sterilization process (e.g. STERILIT® I ,oil spray JG600 for steam sterilization or STERILIT® I ,drip-feed lubricator JG598). ► Check product for proper function:

– Check the sliding ring for good sliding properties. – Check the coupling for self-retaining functionality. – Check clockwise and counter-clockwise rotation. ► Check compatibility with associated Ennovate products having hexagon couplings. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.9

Packaging

► Place the product in its holder or on a suitable tray. Ensure that sharp edges are covered. ► 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

– 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

Maintenance and repair

The torque handles are calibrated by the manufacturer to 5 Nm (SZ229R) or 10 Nm (SZ228R), respectively. The deviation of the actual torque from the nominal torque equals ±10 % at delivery. The service life of the torque handle is 2 years. The service date is indicated on the torque handles. ► Have triggering accuracy checked at regular intervals. ► Do not use the torque handle if the service is overdue. ► Send any torque handle to the contact address for inspection if the service is overdue.

4.2

Technical service

CAUTION Modifications to medical equipment may result in loss of guarantee/warranty claims and any approvals. ► 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.

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.

6.

Symbols on product and packaging Recalibration/maintenance

TA015007

2021-01

V6

Change No. 64056