Ennovate Cervical C1 C2 instruments

en

Aesculap® Ennovate® Cervical C1/C2 instruments Legend

Contents

1 2 3 4 5 6 7

1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 3. 3.1 3.2 3.3 3.4 3.4.1 3.4.2 3.4.3 3.5 3.5.1 3.5.2 3.6

Ennovate Cervical T-handle SZ004R Ennovate Cervical C1/C2 all-in-one guide SZ131R Ennovate Cervical C1/C2 cortical punch SZ132R Ennovate Cervical C1/C2 obturator SZ133R Ennovate Cervical C1/C2 inner drill guide SZ134R Ennovate Cervical C1/C2 drill solid ∅ 2.8 mm SZ136SU/SZ136R Ennovate Cervical C1/C2 & MIS K-wire long ∅ 1.5 mm SZ137SU/SZ137R 8 Ennovate Cervical C1/C2 tap ∅ 4.0 mm SZ139R 9 Ennovate Cervical C1/C2 screwdriver for polyaxial screws long SZ140R 10 Ennovate Cervical C1/C2 ball end screwdriver long SZ141R 11 Ennovate Cervical C1/C2 bone screwdriver shaft SZ142R 12 Ennovate Cervical / S4 Cervical C1/C2 sounder long FW671R The relative size of the instruments does not necessarily reflect their size in reality. The depictions in this document are schematic representations only and may deviate from the actual product.

3.7 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.7.1 4.7.2 4.8 4.8.1 4.8.2 4.9 4.9.1 4.9.2 4.10 4.10.1 4.11 4.11.1 4.11.2 4.11.3

2

About this document... 3 Scope... 3 Safety messages... 3 Clinical use... 3 Areas of use and limitations of use... 3 Intended use... 3 Indications... 3 Contraindications... 3 Safety information... 3 Clinical user... 3 Product... 3 Sterility... 4 Application... 4 Safe application... 4 Prepare all-in-one guide: check desired drill depth... 5 Insert all-in-one guide... 5 Prepare screw hole... 6 Open the cortex... 6 Drill hole... 6 Cut thread with tap (optional)... 6 Insert screw... 7 Polyaxial screws... 7 Bone screws... 8 Align screw head, prepare and insert rod, insert set screw, tighten set screw... 8 Remove Ennovate Cervical C1/C2 implants... 8 Validated reprocessing procedure... 9 General safety instructions... 9 General information... 9 Single-use products... 9 Reusable products... 9 Preparations at the place of use... 9 Preparing for cleaning... 9 Disassembly... 10 Inner drill guide (SZ134R)... 10 All-in-one guide (SZ131R)... 10 Cleaning/Disinfection... 10 Product-specific safety information on the reprocessing method... 10 Validated cleaning and disinfection procedure... 11 Manual cleaning/disinfection... 12 Manual cleaning with immersion disinfection... 12 Manual cleaning with ultrasound and immersion disinfection 13 Mechanical cleaning/disinfection... 14 Mechanical alkaline cleaning and thermal disinfecting... 14 Mechanical cleaning/disinfection with manual pre-cleaning. 15 Manual pre-cleaning with a brush... 15 Manual pre-cleaning with ultrasound and brush... 15 Mechanical alkaline cleaning and thermal disinfecting... 16

en 4.12 4.12.1 4.12.2 4.13 4.13.1 4.13.2 4.14 4.15 4.16 5. 6.

Inspection... Visual inspection... Functional test... Assembly... Inner drill guide (SZ134R)... All-in-one guide (SZ131R)... Packaging... Steam sterilization... Storage... Technical service... Disposal...

1.

About this document

16 16 16 17 17 17 17 17 17 17 17

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

1.1

Scope

These instructions for use are limited to the specificities of the C1/C2 instruments and only apply to the instruments listed on the foldout page. 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 as well as information on mate-

rial 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: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. 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

Areas of use and limitations of use

2.1.1 Intended use The Ennovate Cervical C1/C2 instruments are used for the C1-C2 transarticular screw fixation. Indications and contraindications are described in the instructions for use for the Ennovate Cervical implants TA015777. 2.1.2 Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications.

2.2

Safety information

2.2.1

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. 2.2.2

Product

Product-specific safety information These instructions for use are limited to the specificities of the C1/C2 instruments and only apply to the instruments listed on the foldout page. Several steps are described in the instructions for use for the Basic technique. Refer to the instructions for use of the Basic technique TA015763. The C1/C2 surgical technique is described in the Ennovate Cervical surgical technique (O03102). ► If you navigate, please refer to the operating manual and instructions for use dedicated to navigation. ► Refer to the following documents; Art. no.

Designation

TA015777

IFU ENNOVATE IMPLANT SYSTEM FOR POSTERIOR, OCCIPITAL, CERVICAL AND THORACIC STABILIZATION

TA015763

IFU ENNOVATE CERVICAL BASIC INSTRUMENTS

TA015762

IFU ENNOVATE CERVICAL NAVIGATED INSTRUMENTS

TA015760

IFU ENNOVATE CERVICAL INSTRUMENTS FOR OCCIPITAL FIXATION

TA015755

IFU ENNOVATE CERVICAL TRAYS

O03102

ENNOVATE CERVICAL – SURGICAL TECHNIQUE

O03202

ENNOVATE CERVICAL – NAVIGATION SURGICAL TECHNIQUE

Instruments can fall in situ or on the floor! Handles can loosen during use! ► Check the seating of the coupling handles on the instruments for tightness.

For indications, see Intended use. 2.1.3 Contraindications For contraindications, see Intended use. 3

en Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the case of incorrect application! The patient can suffer from extremely severe complications if instruments or implants are positioned incorrectly! ► Only carry out the alignment and insertion of the instruments and polyaxial screws under radiographic control and/or with the aid of a navigation system. ► Apply the product only under visual control.

3.

2.2.3

DANGER Injury of spinal cord, nerve roots and blood vessels due to piercing the cortex in the case of incorrect application! ► Only carry out the alignment and insertion of the instruments, Kwires and polyaxial screws under radiographic control and/or with the aid of a navigation system. ► Carefully guide the instruments over the K-wires. When doing this, make sure that the K-wire remains in its position. It is recommended to hold the K-wire and to check the striped marking on the K-wire. ► Do not bend the K-wires. Immediately replace bent K-wire. ► Inspect the cannulation of the instruments for blockage before every application.

Sterility

Non-sterile, reusable products Art. no.

Designation

SZ004R

Ennovate Cervical T-handle

SZ131R

Ennovate Cervical C1/C2 all-in-one guide

SZ132R

Ennovate Cervical C1/C2 cortical punch

SZ133R

Ennovate Cervical C1/C2 obturator

SZ134R

Ennovate Cervical C1/C2 inner drill guide

SZ139R

Ennovate Cervical C1/C2 tap ∅ 4.0 mm

SZ140R

Ennovate Cervical C1/C2 screwdriver for polyaxial screws long

SZ141R

Ennovate Cervical C1/C2 ball end screwdriver long

SZ142R

Ennovate Cervical C1/C2 bone screwdriver shaft

FW671R

Ennovate Cervical / S4 Cervical C1/C2 sounder long

► Inspect the new product after removing its transport packaging and

prior to first use to ensure it is in good working order. The product is delivered in a non-sterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Non-sterile, single-use products Art. no.

Designation

SZ136R

Ennovate Cervical C1/C2 drill solid ∅ 2.8 mm

SZ137R

Ennovate Cervical C1/C2 & MIS K-wire long ∅ 1.5 mm

The product is delivered in a non-sterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. ► Do not reuse the product. Sterile, single-use products Art. no.

Designation

SZ136SU

Ennovate Cervical C1/C2 drill solid ∅ 2.8 mm

SZ137SU

Ennovate Cervical C1/C2 & MIS K-wire long ∅ 1.5 mm

The product has been sterilized by irradiation and is supplied in sterile packaging. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date. ► Do not reuse the product. The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

4

Application

Note All handles and handle surfaces are grey. All actuating elements that are actuated during the operation are gold colored. Ennovate Cervical C1/C2 instruments have a black laser marking that is approx. 2 cm long.

3.1

Safe application

When using K-wires, observe the following two warning notices:

DANGER Injury of spinal cord, nerve roots and blood vessels due to bent K-wire or K-wire not holding in the bone! ► Do not reuse K-wires. ► Carefully drive in K-wires. ► Do not bend K-wires. Immediately replace bent K-wires. ► Insert the K-wire in the correct direction, with the roughened end pointing forward. ► Only use K-wires SZ137SU/SZ137R of the C1/C2 Ennovate Cervical system. WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn or missing components. ► Always carry out a function test prior to each use of the product. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. WARNING Risk of injury to patients due to damaged instruments! Ennovate Cervical instruments are precise and can be easily damaged! ► Handle Ennovate Cervical instruments with the greatest of care. ► Do not repair or modify the instruments (e.g. sharpening of the tips). In case of malfunction send them to Aesculap Technical Service.

en 3.2

Prepare all-in-one guide: check desired drill depth 1

4

b 2

4

5

1

2

b a

5

b

a

a

5 2

a

Fig. 2 ► Attach the T-handle 1 (SZ004R) to the obturator 4 (SZ133R): push the

2

Fig. 1 ► Insert the inner drill guide 5 (SZ134R) into the all-in-one guide 2

(SZ131R) until it is fully seated, see Fig. 1 ► Set the desired drill depth: – Push down the golden ‘DEPTH’ marked button a and slide the inner tube b into the inner drill guide 5. – Once the desired depth has been reached, release the button a to lock the inner tube b in place. ► Insert the drill and verify the exposed length of the drill with a caliper (e.g. AA845R). ► Remove the drill and the inner drill guide 5.

3.3

Insert all-in-one guide

DANGER The patient can suffer from severe complications if the all-in-one guide is positioned incorrectly! The position of the all-in-one guide affects all subsequent operative steps! ► When removing instruments (e.g. the obturator) during the procedure, make sure that the all-in-one guide remains firmly in place.

handle 1 onto the hex connection of the obturator 4 up to the stop, see Fig. 2. ► Insert the conical tipped obturator 4 into the all-in-one guide 2 (SZ131R). The obturator 4 locks automatically when it is fully inserted. ► Insert the assembly. Place it at the precise entrance site for the screw, which is just above the inferior edge of the C2 inferior articular process. Once the all-in-one guide 2 is placed its position can be adjusted due to the flexibility of the soft tissue. ► Release the obturator 4 by pushing the golden button a on the all-inone guide 2, see Fig. 2. Note You can first insert the obturator 4 without the all-in-one guide 2. Once the obturator 4 is in place, remove the T-handle 1 from the all-in-one guide 2 and slide the all-in-one guide 2 over the obturator 4. You can rotate the handle of the all-in-one guide 2 by turning the golden knob b at the bottom of the handle in the counter-clockwise direction. Once the position provides the desired ergonomics and optimal imaging, fix the position by turning the knob b in the clockwise direction, see Fig. 2.

DANGER Revision required in case of screw loosening or pedicle break! Damage or breakage of instruments! ► Hold the all-in-one guide axially to the prepared hole and to the K-wire during all operative steps. Avoid levering, bending and strong application of force when doing so. ► Make a stab incision of approx. 1.5 cm through the skin, subcutaneous

tissue and dorsal fascia. The incision can be dilated with hemostatic forceps.

5

en 3.4

Prepare screw hole

3.4.1

Open the cortex 5

3

2

2

5

Fig. 3 ► Insert the inner drill guide 5 (SZ134R) into the all-in-one guide 2 until

it is fully seated. Pull at the inner drill guide 5 to check that it is fully seated. ► Check that the drill depth has not been changed and is still correctly set, see Prepare all-in-one guide: check desired drill depth. ► Insert the cortical punch 3 (SZ132R) to open up the cortical bone layer, as shown at the bottom of the image, see Fig. 3. Note The cortical punch 3 comes into contact with a positive stop in the inner drill guide 5 and protrudes 12 mm (independently of the depth stop). 3.4.2

WARNING Risk of revision (instable fixation / damage to the bone) or damage to the implant or instrument if the prepared hole is too shallow! ► Do not sharpen the drill, as this makes the reading on the depth gauge inaccurate and falsifies the reading. ► Replace blunt drills with new ones. The drill 6 (SZ136SU/SZ136R) can be driven manually with a drill handle palm style (SZ003R) / drill handle tear drop style (SZ002R) or with a motor system and an AO small drill attachment (e.g. GB623R). ► Insert the drill 6 in the handle as described in detail in the instructions for use for Ennovate Cervical Basic instruments TA015763. – Pull back on the locking sleeve, insert the drill 6 up to the stop and release the locking sleeve. – Pull at the drill 6 to check that it is securely coupled. ► Insert the drill 6 into the all-in-one guide 2 and drill the hole under fluoroscopic control through C2 into the lateral mass of C1. ► Check the integrity of the hole using the special long sounder 12 (FW671R), which can be inserted through the all-in-one guide 2. Note A K-wire 7 (SZ137SU/SZ137R) is optionally available to facilitate tapping and screw insertion. It can be inserted through the inner drill guide after drilling. 3.4.3 Cut thread with tap (optional) Like all Ennovate Cervical screws, the screws for this technique are equipped with a self-tapping tip, reducing the need to tap. The use of a tap is recommended in case of a hard bone. This step is optional.

5

Drill hole

7 a

DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue if the inner drill guide is spinning when drilling the holes! ► Make sure that the inner drill guide is fully seated. DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling a hole that is too deep or too shallow! ► Check the laser marked scale on the depth stop. ► Check the drill depth with a caliper before inserting the all-in-one guide. DANGER Injury to spinal cord and nerve roots caused by application of a drill that is too long! ► Use an x-ray image to select an appropriate drill length prior to the operation. ► Align and insert drills only under radiographic monitoring and/or with the aid of a navigation system. ► Select a drill of a length equivalent to the intended drill hole depth. DANGER Risk of injury and damage to the drill if the rotational speed is too high! ► Make sure to set a rotational speed appropriate for the intended application.

6

2

c

a 8

2

b c

b

Fig. 4 The ratchet straight handle c can be moved to the following positions by rotating the collar of the handle, as shown on the left side of the image, see Fig. 4: ■ Forward (IN): for tapping ■ Locked (•): blocks the ratchet ■ Reverse (OUT): for removing tap from the bone

en DANGER Risk of tissue injury or stripping bone threads when inserting the tap! ► Always check the tap advances correctly. DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue if the tap or K-wire goes too deep! ► Check the depth on the laser marked scale. ► Hold the K-wire and check the striped marking on the wire to make sure that the K-wire does not advance unintendedly. ► Attach the tap 8 (SZ139R) to the straight ratchet handle c SZ001R as

described in detail in the instructions for use for Ennovate Cervical Basic instruments TA015763: – Push the handle onto the hex connection of the tap up to the stop. – Set the rotation direction setting on the handle to ‘IN’ (or keep it locked to block the ratchet). ► Remove the inner drill guide 5 from the all-in-one guide 2 by pushing the golden release knob a. ► Insert the tap 8, while maintaining the appropriate trajectory: make sure the all-in-one guide 2 remains axial to the drilled hole. The tap has a scale b to reconfirm the depth. The tap 8 is cannulated to allow guided tapping over a K-wire. When tapping over a K-wire make sure that the K-wire does not advance forward.

3.5

Insert screw

For transarticular screw fixation Ennovate Cervical offers ∅ 4.0 mm cannulated polyaxial favored angle screws and ∅ 4.0 mm solid bone screws. Bone screws are not cannulated and can therefore not be inserted with a K-wire. DANGER Incorrect application can result in trauma to the spinal cord and nerve roots! Severe or fatal hemorrhage as a result of vascular injury! ► Insert the screws under radiographic monitoring and/or with the aid of a navigation system. ► Take care not to breach the lateral cortices when screwing in. ► Make sure that the vessels and nerves 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 and nerves because of close apposition of the implants. WARNING Operation delay! Damage to the polyaxial screw or bone screw if the screwdriver is not well engaged in the screw! Torque cannot be transferred! ► Connect screwdriver completely to the screw. ► Check that the polyaxial screw is solidly fastened to the screwdriver. ► Verify the axial alignment of the polyaxial screw to the screwdriver. Only allow axial load on the screw during screw insertion. Avoid induction of lateral forces. ► Hold the screwdriver axially to the prepared hole when turning in and out. Avoid levering, bending and strong applications of force when doing so.

WARNING Delay of surgery due to wrong screw selection! ► Check the laser marking and color coding. Only use ∅ 4.0 mm screws. ► Bone screws are not cannulated and can therefore not be inserted with a K-wire. ► Attach the straight handle SZ001R to the screwdriver 9 (SZ140R), see

Cut thread with tap (optional). 3.5.1

Polyaxial screws

DANGER Injury to spinal cord, nerve roots and blood vessels due to piercing of the cortex and faulty screw placement due to screw loosening when used improperly! ► Ensure axial alignment of the polyaxial screw to the K-wire when screwing in. When doing this, make sure that the K-wire remains in its position. ► When inserting the screw over the K-wire make sure that the Kwire does not advance forward. It is recommended to hold the Kwire and to check the striped marking on the wire. ► Remove the K-wire before the screw is completely screwed in to ensure that the K-wire does not move forward. ► Do not remove the K-wire too early, otherwise the polyaxial screw guidance will fail. WARNING Risk of injury to the patient if the polyaxial screw is damaged while it is being removed from the packaging! ► When connecting the polyaxial screw with the screwdriver SZ140R never brace against the packaging.

2

9 a

Fig. 5 ► Insert and screw in the screwdriver 9 into the polyaxial screw up to the

stop as described in the instructions for use for Ennovate Cervical Basic instruments TA015763. ► Make sure that the screw is firmly seated on the screwdriver and the polyaxiality is blocked for insertion. ► Insert the screwdriver 9 through the all-in-one guide 2 remaining insitu. ► Insert the screw while maintaining the appropriate trajectory: make sure the all-in-one guide 2 remains axial to the prepared hole. ► After the insertion of the screw, rotate the golden knob a counterclockwise to release the screwdriver. ► Remove the screwdriver. ► Repeat the procedure on the contralateral side.

7

en 3.6

Align screw head, prepare and insert rod, insert set screw, tighten set screw

These steps apply only to polyaxial screws.

L

Fig. 6 Note The screw length L is measured from the tip of the screw to the sphere of the screw shaft, see Fig. 6. To ensure maximum polyaxiality with the screw, do not tighten the screw completely down to the bone. Leave a small gap below the head to allow rotation and angulation of the screw head.

Fig. 8

3.5.2

Bone screws

► After placing the remaining screws and/or the occiput plate, align the

a

b

9

11

screw heads, prepare and insert the rod, insert the set screw and finally tighten as described in the instructions for use for Ennovate Cervical Basic instruments TA015763.

3.7

Remove Ennovate Cervical C1/C2 implants

► Remove the bone screws using the bone screwdriver 9 (SZ140R).

a

b

11

9

2

Fig. 7 ► Insert the tip of the C1/C2 screwdriver 9 (SZ140R) into the bone screw

head, see Fig. 7. ► Insert the bone screwdriver shaft 11 (SZ142R) through the ratchet

handle b (SZ001R) into the C1/C2 screwdriver 9 and turn the knob a to thread the shaft into the screw. ► Insert the C1/C2 screwdriver 9 into the all-in-one guide 2. Screw in the screw by turning the ratchet handle b (SZ001R) while maintaining the appropriate trajectory: make sure the all-in-one guide 2 remains axial to the prepared hole. ► Once the bone screw is placed, turn the knob a counter-clockwise to release the C1/C2 screwdriver shaft 11 from the bone screw. ► Repeat the procedure on the contralateral side.

8

In case of free spinning of the screw the bone screwdriver shaft 11 (SZ142R) can be used to support the removal of the bone screw. For all further information on implant removal, refer to the instructions for use for Ennovate Cervical Basic instruments TA015763.

en 4.

Validated reprocessing procedure

4.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. 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.

4.2

General information

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

4.3

Single-use products

For the list of single use products, see Sterility. ► Do not reuse the product. The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess sterile, single-use products. Intraoperative contamination with blood, secretions, and other fluids may render the affected component unsuitable for resterilization! ► Handle the drills and K-wires with new gloves only. ► Keep the drill and K-wire storage trays covered or closed. ► Process drill and K-wire storage devices/trays separately from instrument trays. ► Clean drills and K-wires must not be cleaned together with contaminated drills and K-wires. ► Reprocess the drills and K-wires individually and separately if no implant system storage devices are available, When doing this, make certain that the implant components are not damaged. ► Do not reuse surgically contaminated drills and K-wires.

4.4

Reusable products

For the list of instruments that can be reused and must be sterilized prior to each use, see Sterility. There is no set maximum number of uses and reprocessing cycles for the product. The life of the product is limited by damage, normal wear and tear, type and duration of use, as well as handling, storage and transport of the product. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

4.5

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized

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

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

disinfection within 6 hours.

4.6

Preparing for cleaning

► Do not disassemble fixation screws which permanently connect the

various components. ► SZ131R and SZ134R: Disassemble the product prior to cleaning, see Disassembly.

9

en 4.7

Disassembly

4.8

4.7.1

Inner drill guide (SZ134R)

4.8.1

b

Cleaning/Disinfection

Product-specific safety information on the reprocessing method 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 – that 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.

a

c

► Use suitable cleaning/disinfecting agents if the product is disposed of

Fig. 9 ► Remove the depth stop b by first pressing the golden button a and pull-

ing the depth stop b out, then turning the depth stop b by 180° (so that the flattened area c is aligned to the arrow) to remove it completely from the guide. 4.7.2

All-in-one guide (SZ131R) b

a

c Fig. 10 ► Rotate the golden knob c counter-clockwise to loosen it. Remove the

inner locking knob a from the handle b

10

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 ► Manually pre-clean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement). ► If the products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

en 4.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free cloth or medical compressed air

Chapter Manual cleaning/disinfection and subsection:

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Drying phase: Use a lint-free cloth or medical compressed air

Chapter Manual cleaning/disinfection and subsection:

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind

Chapter Mechanical cleaning/disinfection and subsection:

■ FW671R ■ SZ131R to SZ134R ■ SZ136R to SZ137R ■ SZ139R ■ SZ141R to SZ142R Manual cleaning with ultrasound and immersion disinfection

■ SZ004R ■ SZ140R Mechanical alkaline cleaning and thermal disinfection

■ SZ132R to SZ133R ■ SZ136R to SZ137R ■ SZ141R to SZ142R ■ FW671R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ SZ131R ■ SZ134R ■ SZ139R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ SZ004R ■ SZ140R

spots).

■ Place products in the tray with their hinges open.

■ Chapter Manual cleaning with immersion disinfection

■ Chapter Manual cleaning with ultrasound and immersion disinfection

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

Chapter Mechanical cleaning/disinfection ■ Suitable cleaning brush with manual pre-cleaning and subsection: ■ 20 ml disposable syringe ■ Chapter Manual pre-cleaning with a ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind brush spots). ■ Chapter Mechanical alkaline cleaning ■ Place products in the tray with their hinges open. and thermal disinfecting ■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

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

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Place products in the tray with their hinges open. ■ Chapter Mechanical alkaline cleaning ■ SZ004R: Rinse lumens using spray nozzle (3.8 bar water pressure) at least 3 and thermal disinfecting times for 20 seconds each.

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

11

en 4.9

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient

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

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

4.9.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

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

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► 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 run-

ning 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 5 times at the beginning of the exposure time

using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened.

12

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

en 4.9.2

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD–W

-

V

Drying

RT

-

-

-

-

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

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection 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 run-

ning 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 run-

ning 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.

13

en 4.10 Mechanical cleaning/disinfection 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. 4.10.1 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

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

ing.

14

en 4.11 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. 4.11.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

► Note the information on appropriate cleaning brushes and disposable

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

syringes, see Validated cleaning and disinfection procedure.

cleaning.

Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

► Thoroughly rinse through these components with the cleaning disin-

fectant 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.

4.11.2 Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection 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.

15

en 4.11.3 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

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

ing.

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

4.12.1 Visual inspection ► Make sure that all dirt has been removed. Pay particular attention to

e.g. fitting surfaces, hinges, shanks, recesses, drilled grooves. ► For contaminated products: repeat the cleaning and disinfection pro-

cess.

4.12.2 Functional test CAUTION Damage (metal seizure / friction corrosion) to the product caused by insufficient lubrication! ► Oil any moving parts (e.g. joints, pusher components 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 instruments having interfaces to the implant for damage, burrs,

► Assemble disassembled products, see Assembly.

or deformation at the corresponding functional geometries as these may damage the implant before use. This applies in particular to: – Star bit geometries (for example screwdrivers) – Surfaces in contact with screw heads (for example screwdrivers 9/10) – Thread geometries for connection to the female thread of the screw head (for example screw driver shaft 11) ► Check the product for damage, e.g. insulation, corroded, loose, bent, broken, cracked, worn, heavily scratched or broken parts. ► Check the product for missing or faded labels and/or paint marks (e.g. color of the handle, gold plating). ► Check the products having long, narrow geometries (in particular rotating instruments) for deformations. ► Check the cutting instruments for sharpness (example tips of punches, drills). ► Check the surfaces for variations in roughness. ► Check the product for burrs that may damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Check the cannulation of the instruments for continuity. ► Immediately put aside damaged or worn products and return them to Aesculap Technical Service, see Technical service.

► Check instruments having interfaces to other instruments for ease of

16

movement and compatibility. ► Make sure that instruments having a square, hexagonal or AO connec-

tion are self-locking in Ennovate handles. ► Check that the obturator 4 and the inner drill guide 5 lock into and

unlock from the all-in-one guide 2. ► Check that the depth stop can be smoothly inserted and locked into the

all-in-one guide 2. ► Check that the product functions correctly. ► Check all moving parts (e.g. hinges, locks/latches, sliding parts etc.) for

full and smooth movement. ► Check locks for secure latching function. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap

Technical Service, see Technical service.

en 4.13 Assembly

4.16 Storage

4.13.1 Inner drill guide (SZ134R)

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

a dry, dark, temperature-controlled area.

a

► Store sterile single-use products in germ-proof packaging in a dust-

protected, dry, dark and temperature-controlled room.

5. b Fig. 11 ► Insert the depth stop while constantly pushing down the golden

button a: – Align the flattened sides b of the depth stop and of the guide. – Insert the depth stop up to the stop – Turn the depth stop by 180° and continue inserting it down to the area of the scale. 4.13.2 All-in-one guide (SZ131R) b

a

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.

6.

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. c Fig. 12 ► Insert the inner locking knob a into the handle b. Rotate the golden

knob c clockwise and tighten the knob.

4.14 Packaging ► Place the product in its holder or on a suitable tray. Ensure that sharp

WARNING Risk of injury due to sharp-edged and/or pointed products! ► When disposing of or recycling the product, ensure that the packaging prevents injury by the product. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure.

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.

4.15 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.

17