S4 Cervical – Instruments

7 2

12 mm

14 mm

1 3 4

8 5 6

en

Aesculap® S4® Cervical Instruments Legend 1 2 3

Twist drill handle FJ839R Bone awl FW041R Depth gauge FW042R, sounder FW044R & long version sounder FW671R 4 Tap FW046R & FW047R 5 Ratchet handle FW165R (non ratchet handle FW067R) 6 Drill FW051SU for 3.5 mm screws (FW052SU for 4.0 mm screws) 7 Variable drill guide FW053R 8 Fixed drill guide FW049R (14 mm) & FW669R (12 mm) 9 Ball end screwdriver FJ968R (long version for favored angle screws FJ988R) 10 Set screw removal screwdriver FW064R 11 Self-holding polyaxial screwdriver FW070R and FW131R (long versions for favored angle screws FW069R and FW132R) 12 Threaded screwdriver FW128R 13 Set screw starters FW058R, FW059R, FW133R and FW134R 14 Counter torque FW062R 15 Torque indicating screwdriver FW061R 16 Torque limiting T-handle FW129R 17 Screw body manipulator FW065R 18 Polyaxial screw revision instrument FW135R 19 Lamina preparator FW071R 20 Rod holding forceps FW076R 21 Straight hook holding forceps FW422R 22 Curved hook holding forceps FW528R 23 Compression forceps FW427R 24 Rod cutter FW082R 25 Straight cut rod cutter FW672R 26 Rod persuader FW084R 27 Rod persuader FW077R 28 Rod persuader ME084R 29 Linear rod persuader FW673R 30 Rod templates FW078R, FW080R and FW081R 31 Rod bending plates FW036R 32 Rod bender FW037R 33 In-Situ rod benders FW073R and FW074R 34 In-Situ rod bender FW136R 35 Favored angle guide sleeve FW066R 36 Apfelbaum C1-C2 obturator FJ983R 37 Apfelbaum trocar FJ984R 38 Favored angle screw tap FW089R 39 Favored angle screw drill FW088SU 40 Apfelbaum inner sleeve guide FJ985R 41 Occipital screwdriver FW213R 42 Occipital plate bending pliers FW090R 43 Drill bit for occipital plate screws 4.5 mm FW091SU (5.5 mm FW092SU) 44 Tap for occipital plate screws 4.5 mm FW093R (5.5 mm FW094R) 45 Occipital drill guide double ended for 4.5 mm screws FW095R (for 5.5 mm screws FW096R), Occipital tap guide double ended for 4.5 mm screws FW097R (for 5.5 mm screws FW098R) 2

46 Occipital screw remover FW099R 47 Occipital screw removal shaft FW101R 48 Occipital T-handle for screw removal FW116R 49 Occipital flexible set screw starter FW109R 50 Occipital torque wrench FW103R 51 Occipital counter torque handle FW104R 52 Guide tube for smooth shank screws FW054R 53 Smooth shank bone awl FW085R 54 Smooth shank drill with depth gauge FW086SU 55 Smooth shank screw tap FW087R 56 Rod pusher FW063R 57 Distraction forceps, curved FW428R 58 Distraction forceps, straight FW523R 59 Pedicle probe FW045R 60 Bone probe straight FW674R 61 Bone probe curved FW675R 62 Bone probe blunt straight FW676R 63 Bone probe blunt curved FW677R 64 Bone probe thoracic straight FW678R 65 Bone probe thoracic curved FW679R

Contents 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 2.3 2.3.1 2.3.2 2.3.3 2.3.4 2.3.5 2.3.6 2.3.7 2.3.8 2.3.9 3. 3.1 3.2 3.3 3.4 3.5 3.6

About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Application... Preparing the holes for S4 Cervical screws... Drilling the holes for S4 Cervical screws... Tapping (optional)... Positioning and temporary fixation of an S4 Cervical screw . . Adapting the S4 Cervical rods... Rod persuader (26, 27, 28, 29)... Insertion of set screw... Removing the S4 Cervical implants... Pseudo rod revision instrument... Validated reprocessing procedure... General safety instructions... General information... Single-use products... Reusable products... Preparations at the place of use... Preparing for cleaning...

3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 5 5 6 6 7 7 7 7 7 7 8 8 8 8

en 3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.7.5 3.7.6 3.7.7 3.8 3.8.1

3.12 3.12.1 3.12.2 3.13 3.13.1 3.13.2 3.13.3 3.13.4 3.13.5 3.13.6 3.13.7 3.13.8 3.14 3.15 3.16 4. 5.

Disassembly... 8 Twist drill handle (1)... 8 S4 Cervical tap (4)... 8 S4 Cervical self holding polyaxial screwdriver (11)... 8 Rod persuader (26)... 8 S4 Cervical TH Threaded screwdriver (12)... 9 Linear rod persuader (29)... 9 Occipital drill guide and tap guide (45)... 9 Cleaning/Disinfection... 10 Product-specific safety information on the reprocessing method... 10 Validated cleaning and disinfection procedure... 10 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 Mechanical neutral or mild alkaline cleaning and thermal disinfecting... 16 Inspection... 17 Visual inspection... 17 Functional test... 17 Assembly... 17 Twist drill handle (1)... 17 S4 Cervical tap (4)... 17 S4 Cervical self holding polyaxial screwdriver (11)... 17 Rod persuader (26)... 17 S4 Cervical TH Threaded screwdriver (12)... 17 Linear rod persuader (29)... 18 Straight cut rod cutter (25)... 18 Occipital drill guide and tap guide (45)... 18 Packaging... 19 Steam sterilization... 19 Storage... 19 Technical service... 19 Disposal... 19

1.

About this document

3.8.2 3.9 3.9.1 3.9.2 3.10 3.10.1 3.11 3.11.1 3.11.2 3.11.3 3.11.4

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

1.1

Scope

These instructions for use apply for S4® Cervical Instruments.

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 S4 Cervical system (S4C system) is used for posterior occipital cervical and thoracic stabilization and fusion. 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. Indications are specified in the instruction for use for the implants (TA011796). 2.1.3 Contraindications Contraindications are specified in the instruction for use for the implants (TA011796).

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.

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

3

en 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 ► Always follow the instructions for use of the S4 Cervical Implants (TA011796) and the respective operating manual. ► Observe the surgical technique of the S4 Cervical system O34202. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Inspect the product after each cleaning and disinfecting cycle to be sure that it is clean, functioning properly and not damaged. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar). ► Do not use products that are in open or damaged sterile packaging. ► Do not use the product after its use-by date. 2.2.3 Sterility The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Single-use products (FW051SU, FW052SU, FW086SU, FW088SU, FW091SU, FW092SU) The product has been radiation-sterilized and is supplied in sterile packaging. ► Do not reuse the product. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use. ► Do not use products from open or damaged sterile packaging. ► Prior to each use, inspect the product for loose, bent, broken, cracked or fractured components. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date.

2.3

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. 2.3.1 Preparing the holes for S⁴ Cervical screws The holes for self-tapping S4 Cervical screws are started using the S4 Cervical bone awl 2. The cortical layer of the vertebral body is penetrated in this process. A raised edge is provided on the standard bone awl 2 which provides an indication as to when the ideal depth has been reached.

Fig. 1

Awl fully inserted

Opening the cortical layer with the bone awl 2 DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when inserting the bone awl! ► Never insert the awl beyond the raised edge, see Fig 1. 2.3.2

Drilling the holes for S⁴ Cervical screws

DANGER Risk of injury from an incorrectly placed hole or a hole that is too deep! ► Do not sharpen the drill, as this makes it the reading on the depth gauge inaccurate and falsifies the reading. ► Replace blunt drills with new ones. The drill is applied with a drill guide and can be driven manually with twist drill handle 1 or with a motor system and Aesculap intra handpiece (e.g., GD45OR/GD456R). Mounting the drill and handle (only for manual drilling)

Fig. 2

Mounting the drill

► Use twist drill handle 1 for manual drilling.

4

en DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when drilling the holes! ► Always use the correct S4 Cervical drilling guides when drilling the holes. Do not combine drills and guides incorrectly. ► Always check the drill lengths with the guide sleeve being used using a caliper (e.g., AA845R, Caspar instrument for anterior cervical fusion) before starting to drill. DANGER Injury to spinal cord and nerve roots caused by application of a drill that is too long! ► Use x-ray image to select an appropriate drill length prior to the operation. ► Alignment and insertion of the drills may only be executed under radiographic monitoring and/or aided by a navigation system. ► Select a drill of a length equivalent to the intended drill hole depth. ► To insert drill in twist drill handle 1:

– Pull back locking sleeve against the spring pressure, in the direction indicated by the arrow and hold it there. – Push drill into the adapter of twist drill handle as far as it will go. – Slightly twist drill while releasing locking sleeve.

► Check the length to be drilled prior to drilling by inserting the drill in

the guide and measuring the cutting depth with a caliper (e.g., AA845R). ► Drill to the preset depth. The stop unit stops the drill on the guide sleeve. 2.3.3 Tapping (optional) S4 Cervical screws are self-tapping screws. However, if the bone quality is found to be hard, the operating surgeon can decide to pre-tap the thread with the S4 Cervical tap. DANGER Risk of tissue injury when inserting the S4 Cervical tap or stripping bone threads! ► Always check if the sleeve retracts correctly prior to applying the S4 Cervical tap. ► To tap the thread:

– Slowly drive the S4 Cervical tap 4 in steadily until the required depth is reached. – The depth is read from the scale as the sleeve retracts during tapping.

Fig. 5

Depth is read from scale

2.3.4

Positioning and temporary fixation of an S⁴ Cervical screw

Picking up the S⁴ Cervical screw ► Pick up the S4 Cervical screw with the S4 Cervical self holding polyaxial

screwdriver 11.

Fig. 3

Drill engages audibly

DANGER Risk of injury and damage to the drill if the rotational speed is too high! ► Be sure to set a rotational speed appropriate for the intended application.

Fig. 6

Picking up the S4 Cervical screw

► To prevent the S4 Cervical screw from dropping out of the S4 Cervical

self holding polyaxial screwdriver 11 during transfer to the operating surgeon, lock the instrument by pulling back and releasing the blue knob. ► Make sure that the S4 Cervical screw is firmly seated on the S4 Cervical self holding polyaxial screwdriver and the polyaxiality of the screw is blocked for insertion.

Fig. 4

Drilling with the drill guide (FW053R, FW049R or FW669R)

► For the variable drill guide 7, set the depth to be drilled on the depth

stop by rotating the plastic collar on the guide sleeve. The fixed drill guide (14 mm) 8 has a green handle. The fixed drill guide (12 mm) 8 has a red handle.

Using the S⁴ Cervical TH threaded screwdriver 12 ► Hold the S4 Cervical screw body in one hand. ► Insert the S4 Cervical TH threaded screwdriver 12 into the S4 Cervical screw hex. ► To affix the S4 Cervical TH threaded screwdriver 12 to the screw, rotate the blue handle clockwise until the screwdriver thread engages the screw thread. ► Tighten until resistance is felt. Do not overtighten as this can cause difficulty disengaging the screwdriver after screw placement. ► After insertion of the S4 Cervical screw into the patient: Rotate the blue handle counter-clockwise to release the S4 Cervical TH threaded screwdriver 12.

5

en 2.3.5 Adapting the S⁴ Cervical rods The Aesculap S4 Cervical rods are supplied straight (excluding pre-bent for occipital plate). Their curvature can be adjusted to the situation or to the required spine lordosis using the S4 Cervical bending instruments. ► Use the rod templates 30 for examining the degree of rod bend required. Note For long S4 Cervical rods, bending should be carried out in several steps in order to avoid excessive or insufficient lordosis. DANGER Damage to and breakage of the S4 Cervical rods caused by excessive strain on the material! ► Always bend the S4 Cervical rods in one direction only. Do not bend back the S4 Cervical rods. ► Always use S4 Cervical bending instruments (e.g., 31, 32, 33, 34) for bending S4 Cervical rods. ► Avoid small bending radii, bending back, notching or scratching of S4 Cervical rods. ► To bend the S4 Cervical rods close to their ends, use the rod bending

plates 31. DANGER Risk of damage to patient, personnel or equipment in the operating room due to flying fragment from cut rod! ► Always hold the piece of rod to be cut at both ends. ► To cut the S4 Cervical rods use the rod cutter 24 or 25.

Fig. 7

► To cut the S4 Cervical rods with rod cutter 25:

► Likewise hold the S4 Cervical hooks using the S4 Cervical hook holding

– Ensure that the handles of the rod cutter are in the free, relaxed and open position. – Rotate the large knob clockwise until both lines match between the body of the device and the rotating knob. – Mark the cutting location on the rod. – Slide the rod into the center hole of the rod cutter through the rotating knob until the mark on the rod is approximately at the location of the cut line. The rod will be cut at the side of the rod cutter marked with “cut location”. – Squeeze handles together until they come close together. – Release pressure on the handles and allow them to fully open again to the relaxed position. – Repeat several times until the rod is fully cut and can easily be removed from the rod cutter. If desired, sharp edges left after cutting the rod can be filed with a suitable instrument such as the Aesculap durogrip file OL429R. ► Hold the rod during insertion using the S4 Cervical rod holding forceps 20.

6

Holding the rod

forceps 21, 22. 2.3.6

Rod persuader (26, 27, 28, 29)

CAUTION Damage to and breakage of the rod persuader! ► Never use the rod persuader to bend the S4 Cervical rod. ► Never use the rod persuader to act as a counter torque for the S4 Cervical set screws. ► To persuade with rod persuader 28 or 29:

– Make sure that the persuader is placed axial to the screw head. – Slide the persuader blades over the screw head so that the persuader reaches its operational point. – Make sure that the pins of the persuader blades interface with the holes in the head of the polyaxial screw. – Make sure that both pins of the persuader blades engage the holes of the polyaxial screw. – Make sure to hold the persuasion knob as the passage of the set screw may be obstructed by deflection of the hinge when holding the linear rod persuader 29 by the outer sleeve.

en 2.3.7

Insertion of set screw

CAUTION Damage to the S4 Cervical screw caused by incorrectly applying the torque indicating screwdriver 15 when driving in the set screws! This screwdriver is an indicating instrument. Align the two opposing arrows to apply the proper torque. ► Always use the counter torque instrument 14 when tightening the S4 Cervical set screw in the S4 Cervical screw body. ► Refer to TA011947 for further information. CAUTION Damage to the S4 Cervical screw caused by incorrectly applying the set screw removal screwdriver 10 and torque limiting T-handle 16 when driving in the set screws! ► Ensure that the set screw removal screwdriver 10 is securely connected to the torque limiting T-handle 16. ► Always use the counter torque instrument 14 when tightening the S4 Cervical set screw in the S4 Cervical screw body. CAUTION Damage to the S4 Cervical implants caused by incorrectly applying the occipital flexible set screw starter 49 when driving in the set screws! ► Refer to TA012676 S4 Cervical occiput mini set screw starter flexible shaft. 2.3.8

Removing the S4 Cervical implants

CAUTION Damage to the S4 Cervical torque indicating screwdriver 15! ► Never use the S4 Cervical torque indicating screwdriver 15 for extracting screws. ► Use the S4 Cervical set screw removal screwdriver 10 together with the handle 5 and counter torque 14 when extracting set screws. CAUTION Damage to the S4 Cervical implants caused by incorrectly applying the occipital torque wrench 50 when driving in the set screws! ► When tightening the set screw always apply counter torque using the countering instrument for this purpose. ► Refer to TA012367 S4 Cervical Spinal System - torque wrenches with click function. 2.3.9

Pseudo rod revision instrument

CAUTION Damage to and breakage of the pseudo rod revision instrument! ► Never use the pseudo rod revision instrument to release a locked S4 Cervical polyaxial screw tulip.

3.

Validated reprocessing procedure

3.1

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.

3.2

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".

7

en 3.3

► Loosen and unscrew nut and remove it from the sleeve in the direction

Single-use products

■ FW051SU ■ FW052SU ■ FW086SU ■ FW088SU ■ FW091SU ■ FW092SU

of the arrow. ► Remove sleeve together with the spring in the direction of arrow. 3.7.3

S⁴ Cervical self holding polyaxial screwdriver (11)

► 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.

3.4

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 opportunity to recognize a product that is no longer functional, see Inspection.

3.5

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.

3.6

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly

and

TA012367. ► Open up product with hinges.

3.7

Disassembly

3.7.1

Twist drill handle (1)

Fig. 10 Exploded view of S4 Cervical self holding polyaxial screwdriver Note These instructions are also valid for FW070R, FW131R, FW069R, FW132R. CAUTION The screwdriver will not function properly if the retaining tongues are bent or crimped! ► Do not bend or crimp the retaining tongues. ► Pull back on blue knob (black for FW069R and FW132R). ► Loosen and unscrew the screw sleeve at the working end of the instru-

ment. ► Keep the blue knob (black for FW069R and FW132R) pulled back until

the screw sleeve is completely unscrewed. ► Slide the knob and the retaining tongues towards the working end of

the instrument and off the screwdriver shaft. ► Remove the spring.

3.7.4

Fig. 8

Rod persuader (26)

Disassembling of twist drill handle

► Pull off twist drill handle 1 from collar in the direction indicated by the

arrow. 3.7.2

S⁴ Cervical tap (4)

Fig. 11 Disassembling of rod persuader ► Pull the release mechanism on the back handle to the downward posi-

tion and maintain this position until the rear handle has been removed. ► Holding the outer shaft pull the front handle towards the rear of the

persuader until fully disassembled. Fig. 9

8

Disassembling of taps

en 3.7.5

► Press the circular tabs of the hinge.

S⁴ Cervical TH Threaded screwdriver (12)

This will lift the pins out of the inner sleeve, enabling it to be pulled out of the outer sleeve.

A

B

C

A

Fig. 12 Disassembling the threaded screwdriver ► Hold the screwdriver 12 at the distal or hex end. ► Turn the adapter for handle A on the back end of instrument counter-

clockwise.

Fig. 15 Pulling out the inner sleeve ► Remove the locking sleeves by rotating them out from under the knob.

► Remove the screwdriver shaft B through the handle-sleeve assembly C.

3.7.6

Linear rod persuader (29)

► Ensure the proximal knob is in the unlock extended position.

This will retract the locking sleeves from the inner sleeve.

Fig. 16 Removing the locking sleeves Fig. 13 Proximal knob is in the unlock extended position

3.7.7

Occipital drill guide and tap guide (45)

► Turn the persuasion nut as if persuading the rod until the screw threads

are no longer engaged.

Fig. 14 Turning the persuasion nut

Fig. 17 Removing the sleeves ► Remove the sleeves by rotating them out clockwise.

9

en 3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method Danger to the patient! FW672R must not be manually reprocessed. ► Reprocess FW672R only by manually pre-cleaning followed by cleaning in a mechanical washer/disinfector. 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 aluminium, plastics, 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. ► If the microsurgical products can be securely fixed in machines or stor-

age devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically. 3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ For FJ839R, FJ968R, FJ983R, FJ984R, FJ988R, FW036R, FW037R, FW041R, FW042R,

Chapter Manual cleaning/disinfection and subsection:

FW044R, FW045R, FW046R, FW047R, FW049R, FW053R, FW058R, FW059R, FW061R, FW062R, FW063R, FW064R, FW065R, FW066R, FW069R, FW070R, FW071R, FW073R, FW074R, FW076R, FW078R, FW080R, FW081R, FW085R, FW087R, FW089R, FW093R, FW094R, FW095R, FW096R, FW097R, FW098R, FW099R, FW101R, FW103R FW104R, FW109R, FW131R, FW132R, FW133R, FW134R, FW135R, FW136R, FW213R, FW422R, FW427R, FW528R, FW669R, FW671R, FW674R, FW675R, FW676R, FW677R, FW678R, FW679R

■ Chapter Manual cleaning with immersion disinfection

■ Cleaning brush: e.g., TA011327, TA006874 for FW095R, FW096R, FW097R, FW098R ■ Disposable syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

■ Drying phase: Use a lint-free cloth or medical compressed air Manual cleaning with ultrasound and immersion disinfection

■ For FJ985R, FW054R, FW067R, FW077R, FW082R, FW084R, FW090R, FW116R, FW128R, FW129R, FW165R, FW428R, FW523R, FW673R, ME084R

■ Chapter Manual cleaning with ■ Cleaning brush: e.g. TA011944 ultrasound and immersion ■ Disposable syringe 20 ml disinfection ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

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

10

Chapter Manual cleaning/disinfection and subsection:

en Validated procedure

Specific requirements

Reference

Mechanical alkaline cleaning and thermal disinfection

■ For FJ968R, FJ983R, FJ984R, FJ988R, FW037R, FW041R, FW042R, FW044R, FW045R,

Chapter Mechanical cleaning/disinfection and subsection:

FW058R, FW059R, FW061R, FW062R, FW063R, FW064R, FW065R, FW066R, FW071R, FW073R, FW074R, FW076R, FW078R, FW080R, FW081R, FW085R, FW087R, FW089R, FW093R, FW094R, FW098R, FW101R, FW103R, FW109R, FW133R, FW134R, FW135R, FW136R, FW422R, FW528R, FW671R, FW674R, FW675R, FW676R, FW677R, FW678R, FW679R

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). ■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ To flush the product: Use a flushing nozzle or flushing sleeve. ■ Keep working ends open for cleaning. ■ Place products in the tray with their hinges open. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ For FJ839R, FW036R, FW046R, FW047R, FW049R, FW053R, FW054R, FW069R, FW070R, FW077R, FW095R, FW096R, FW097R, FW099R, FW104R, FW131R, FW132R, FW213R, FW427R, FW428R, FW523R, FW669R

Chapter Mechanical cleaning/disinfection with manual precleaning and subsection:

■ Chapter Manual pre-cleaning ■ Cleaning brush: e.g. TA011327, TA006874 for FW095R, FW096R, FW097R, FW098R with a brush ■ Disposable syringe 20 ml ■ Chapter Mechanical alkaline ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). cleaning and thermal disinfecting ■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ To flush the product: Use a flushing nozzle or flushing sleeve. ■ Keep working ends open for cleaning. ■ Place products in the tray with their hinges open. Manual pre-cleaning with brush and subsequent mechanical neutral or mild alkaline cleaning and thermal disinfection

■ For FW672R ■ Suitable cleaning brush ■ Disposable syringe 20 ml ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

Chapter Mechanical cleaning/disinfection with manual precleaning and subsection:

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

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

■ For FJ985R, FW067R, FW082R, FW084R, FW090R, FW116R, FW128R, FW129R, FW165R, FW673R, ME084R

Chapter Mechanical cleaning/disinfection with manual precleaning and subsection:

■ Cleaning brush: e.g. TA011944 ■ Chapter Manual pre-cleaning ■ Disposable syringe 20 ml with ultrasound and brush ■ Mount jaws protection on the product. ■ Chapter Mechanical alkaline cleaning and thermal disin■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots). fecting ■ Connect components with lumens and channels directly to the rinsing port of the injector carriage.

■ To flush the product: Use a flushing nozzle or flushing sleeve. ■ Keep working ends open for cleaning. ■ Place products in the tray with their hinges open.

11

en 3.9

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.

3.9.1

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. 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.

12

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

en 3.9.2

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 3.10 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. 3.10.1 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 3.11 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. 3.11.1 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

► Thoroughly rinse through these components with the cleaning disin-

syringes, see Validated cleaning and disinfection procedure.

fectant solution (at least five times), using a disposable syringe.

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.

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.

3.11.2 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 3.11.3 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.

3.11.4 Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device 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

Neutral:

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline:

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution III

Intermediate rinse

> 10/50

1

FD-W

-

IV

Thermal disinfecting

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 neutral

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

ing. ► Repeat the cleaning/disinfecting process if necessary.

16

en 3.12 Inspection

3.13 Assembly

► Allow the product to cool down to room temperature.

3.13.1 Twist drill handle (1) ► Push handle onto collar against the direction indicated by the arrow, see Fig. 8.

► Dry the product if it is wet or damp.

3.12.1 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 the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► 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. 3.12.2 Functional test CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

3.13.2 S⁴ Cervical tap (4) ► Slide guide sleeve with spring over the tap against the direction of the arrow and fasten it by turning the nut clockwise, see Fig. 9. 3.13.3 S⁴ Cervical self holding polyaxial screwdriver (11) Note These instructions are also valid for FW070R, FW131R, FW069R, FW132R. CAUTION The screwdriver will not function properly if the retaining tongues are bent or crimped! ► Do not bend or crimp the retaining tongues. ► Replace the spring on the shaft. ► Slide the knob with retaining tongues onto the screwdriver shaft in

such a way that the retaining tongues engage the grooves of the screwdriver shaft, see Fig. 10. ► Pull back on blue knob (black for FW069R and FW132R). ► Screw the screw sleeve onto the tip of the screwdriver and tighten it down. ► Keep the blue knob (black for FW069R and FW132R) pulled back until the screw sleeve is completely tightened. 3.13.4 Rod persuader (26)

► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges,

locks/latches, sliding parts etc.). ► Check rotating products (e.g. reusable drills and cutters) for bends and

deformities. To do this, roll the product on an even surface. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

Fig. 18 Assembling of rod persuader ► Align the gripping end with the outer shaft and carefully depress the

gripping fingers inward until secured in the outer shaft. ► Position the rear handle concentrically with the outer shaft and apply

pressure until an audible click is heard confirming locking. ► Squeeze the handle to verify successful assembly.

3.13.5 S⁴ Cervical TH Threaded screwdriver (12) ► Slide screwdriver shaft B through the handle-sleeve assembly C, see Fig. 12. ► Insert the adapter for handle A onto screwdriver shaft B. ► Turn the adapter for handle A clockwise and fully tighten thread. ► Make certain the adapter for handle A is threaded onto screwdriver shaft B.

17

en 3.13.6 Linear rod persuader (29) ► Engage the locking sleeves into the proximal nut by rotating them into the groove of the knob.

► Re-engage the persuasion nut and thread completely to the starting

position to prepare for use.

Fig. 22 Re-engaging the persuasion nut 3.13.7 Straight cut rod cutter (25) ► Apply Aesculap STERILIT® lubricant as needed. Fig. 19 Engaging the locking sleeves ► Slide the inner assembly into the outer sleeve.

Fig. 23 Applying lubricant 3.13.8 Occipital drill guide and tap guide (45) Fig. 20 Sliding the inner assembly into the outer sleeve ► Press the circular tabs of the hinge to lift the pins and slide the inner

tube into position.

Fig. 24 Reengaging the sleeves Fig. 21 Sliding the inner tube into the position

► Reengage the sleeves completely to the starting position by rotating

them counterclockwise.

18

en 3.14 Packaging

5.

Disposal

► Appropriately protect products with fine working tips. ► Store products with ratchet locks fully opened or locked no further

than in the first notch. ► 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.

3.15 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition.

WARNING Risk of infection due to contaminated products! ► Adhere to national regulations when disposing of or recycling the product, its components and its packaging. 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.

Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► 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.

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

a dry, dark, temperature-controlled area. ► Store sterile single-use products in germ-proof packaging in a dust-

protected, 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. 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.

19