S4 Cervical – Navigated Instruments

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Aesculap® S4® Cervical Navigated Instruments Legend A B C D E F G H I J K L M N O P Q R S

Navigated tapper Ø 3.5 mm (FW655R) Reference star unit (pre-calibrated) (Brainlab Art. no. 55830-20A) Handle (FW165R with ratchet or FW067R without ratchet) Navigated screwdriver for polyaxial screw (FW656R) Reference star unit ML (calibration with ICM4) (Brainlab Art. no. 55830-25A) Navigated drill guide Ø 3.5 mm (FW664R) Navigated drill guide Ø 4.0 mm (FW665R) Aesculap star unit navigation attachment (FW652R) Navigated guide sleeve Ø 4.0 mm for smooth-shaft screws (FW658R) Reduction sleeve Ø 13 mm for Brainlab instrument calibration matrix version 4 (FW657R) Navigated guide sleeve Ø 3.5 mm/4.0 mm (FW660R) C1/C2 inner drill sleeve Ø 4 mm (FJ985R) C1/C2 inner drill sleeve Ø 3.5 mm (FW661R) C1/C2 drill Ø 2.4 mm (FW662SU) C1/C2 tapper Ø 3.5 mm (FW663R) Centering tool for navigated drill guide Ø 3.5 mm FW664R (FW688R) Centering tool for navigated drill guide Ø 4.0 mm FW665R (FW689R) Drill Ø 2.4 mm for FW664R (FW666SU) Drill Ø 2.9 mm for FW665R (FW667SU)

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 3. 3.1 3.2 3.3 2

About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product-specific safety information... Sterility... Application... Preparing holes for S4C screws with navigation... Drilling holes for the S4C screws... Drilling holes for S4C screws Ø 3.5 mm/4.0 mm... Tapping (optional)... Position S4C screw under navigation and temporarily fix it in place... Smooth-shaft screw instruments... Instruments for Favored Angle screws... Standard screw (Ø 3.5 mm) instrumentation with Favored Angle instruments... Validated reprocessing procedure... General safety instructions... General information... Single-use products...

3 3 3 3 3 3 3 3 3 3 3 4 4 5 5 6 7 7 8 9 10 11 11 11 12

3.4 3.5 3.6 3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.7.5 3.8 3.8.1 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 3.12 3.12.1 3.12.2 3.13 3.13.1 3.13.2 3.13.3 3.13.4 3.13.5 3.14 3.15 3.16 4. 5.

Reusable products... 12 Preparations at the place of use... 12 Preparing for cleaning... 12 Disassembly... 12 S4C navigated tapper Ø 3.5 mm FW655R... 12 S4C navigated screwdriver FW656R... 12 S4C navigated drill sleeve Ø 3.5 mm (FW664R)/Ø 4.0 mm (FW665R)... 12 S4C navigated guide sleeve for smooth-shaft screws, FW658R 12 S4C navigated guide sleeve Ø 3.5 mm/4.0 mm FW660R... 13 Cleaning/Disinfection... 13 Product-specific safety information on the reprocessing method... 13 Validated cleaning and disinfection procedure... 13 Manual cleaning/disinfection... 15 Manual cleaning with immersion disinfection... 15 Manual cleaning with ultrasound and immersion disinfection 16 Mechanical cleaning/disinfection... 17 Mechanical alkaline cleaning and thermal disinfecting... 17 Mechanical cleaning/disinfection with manual pre-cleaning. 18 Manual pre-cleaning with a brush... 18 Manual pre-cleaning with ultrasound and brush... 19 Mechanical alkaline cleaning and thermal disinfecting... 19 Inspection... 20 Visual inspection... 20 Functional test... 20 Assembly... 20 S4C navigated tapper Ø 3.5 mm, FW655R... 20 S4C navigated screwdriver FW656R... 20 S4C navigated drill sleeve Ø 3.5 mm (FW664R)/Ø 4.0 mm (FW665R)... 20 S4C navigated guide sleeve for smooth-shaft screws, FW658R 20 S4C navigated guide sleeve Ø 3.5 mm/4.0 mm, FW660R... 21 Packaging... 21 Steam sterilization... 21 Storage... 21 Technical service... 21 Disposal... 21

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About this document

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

1.1

Scope

These instructions for use apply for S4 Cervical – Navigated Instruments. 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 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. 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-specific safety information ► Observe the surgical technique of the S4® Cervical system O34202. The instruments listed in the key form part of this system. They are used for the individual adaptation, positioning and insertion of S4C implants in patients. For safe usage, follow instructions for use for S4C System Instruments (TA011984) and Operating Techniques (O34202/O83002) The instruments listed in the key may only be used with the Brainlab navigation system. For safe handling prior to the operation, read Spine & Trauma user manual for Brainlab instruments and the corresponding software manual for the Brainlab spine application used. Combination specifications Note Aesculap and Brainlab accept absolutely no responsibility if instruments, centering tools or drills other than those named below are used with the corresponding drill guides and guide sleeves.

■ Only combine S4C navigated drill guide F with: – S4C centering tool P for S4C drill guide F – S4C drill R Ø 2.4 mm for Ø 3.5 mm screws ■ Only combine S4C navigated drill guide G with: – S4C centering tool Q for drill guide G – S4C drill S Ø 2.9 mm for Ø 4.0 mm screws ■ Only combine S4C navigated guide sleeve Ø 4.0 mm I for smoothshank screws with: – Smooth-shaft screw bone awl (FW085R) – Drill for Ø 2.9 mm smooth-shaft screws (FW086SU) – Smooth-shaft (Shank) screw tapper (Tap) (FW087R) – Polyaxial screwdriver (FW070R/FW131R) – Navigated screwdriver for polyaxial screw (FW656R) – Apfelbaum ball head screwdriver, short (FJ968R)

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en ■ Only combine S4C navigated guide sleeve Ø 3.5 mm/4.0 mm K with: – – – – – – – – – –

Apfelbaum C1/C2 obturator (FJ983R) Apfelbaum trocar (FJ984R) Favored Angle screw drill Ø 2.9 mm for Ø 4 mm screws (FW088SU) Favored Angle tapper (Tap)Ø 4 mm (FW089R) C1/C2 inner drill sleeve Ø 4 mm L (FJ985R) S4C Favored Angle screwdriver (FW069R/FW132R) C1/C2 drill Ø 2.4 mm for Ø 3.5 mm screws (FW662SU) N C1/C2 tapper (Tap) Ø 3.5 mm (FW663R) O C1/C2 inner drill sleeve Ø 3.5 mm (FW661R) M Apfelbaum ball head screwdriver (FJ988R)

Note K-wires generally may not be used with the S4C 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 Art. no.

Designation

FW086SU

Drill Ø 2.9 mm for smooth-shaft screws

FW088SU

Favored Angle screw drill Ø 2.9 mm for Ø 4 mm screws

FW662SU

S4 C1/C2 drill Ø 2.4 mm

FW666SU

Drill Ø 2.4 mm

FW667SU

Drill Ø 2.9 mm

► 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. The product is gamma-sterilized and supplied in sterile packaging. ► Ensure that the product and its accessories are operated and used only

by persons with the requisite training, knowledge, or experience. ► 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 prod-

uct if it is damaged. ► Do not use the product after its use-by date.

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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. WARNING Risk of injury to patients due to damaged instruments! S4C instruments are extremely precise and very sensitive. ► Handle S4C instruments with the greatest of care. ► Check that dropped or damaged S4C instruments are accurately calibrated, or send them to the Aesculap Technical Service. WARNING Risk of injury to patients due to interruption of the navigation! ► Prior to the operation, plan the configuration of the operating room, the assembly of the instruments and the alignment of the reference star. ► Ensure that the navigation camera has an unrestricted view of the reflective marker spheres of the instruments. WARNING Risk of injury to patients due to imprecise instruments! ► Ensure that the instruments used are not bent or damaged. ► Before use, check the precision of the instruments, particularly that of fine instruments. For this, hold the instrument tip in the pivot point of the Brainlab instrument calibration matrix version 4. WARNING Risk of injury to patients due to incorrect navigation! ► Use navigated S4C instruments only with Brainlab disposable reflective marker spheres. ► For further information on the correct handling of the marker spheres, see corresponding Brainlab user manual.

en 2.3.1

Preparing holes for S4C screws with navigation

WARNING Risk of injury to patients due to incorrect navigation! ► Observe the combination specifications

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F/G

To center the screw holes in the cortical bone layer for the self-tapping S4C screws Ø 3.5 mm with navigation, use the S4C navigated drill guide Ø 3.5 mm F only together with S4C centering tool for S4C navigated drill guide P. To center the screw holes for the self-tapping S4C screws Ø 4.0 mm with navigation, use the S4C navigated drill guide Ø 4.0 mm G only together with S4C centering tool for S4C navigated drill guide Q. S4C navigated drill guide G and centering tool Q have a purple marking on the shaft for the self-tapping S4C screws Ø 4.0 mm, see Fig. 1.

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P/Q

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Mounting the Aesculap star unit on S4C drill guide FW664R/FW665R

► Prior to each use, check and/or validate the instrument with the

G

Fig. 1

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Purple markings on S4C navigated drill guide and centering tool

To center the screw holes in the cortical layer without navigation, see instructions for use of S4 Cervical instruments (TA011984). WARNING Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue when inserting the centering tool without drill guide! ► Use the centering tool only with drill guide FW664R/FW665R. CAUTION Restriction of the function of the centering tool or inaccurate reading of the depth gage! ► Do not repoint the centering tool. ► Replace blunt centering tools. ► For mounting the reflective Brainlab marker spheres 4 onto Aesculap

star unit H, see Brainlab user manual. ► Retract and hold locking sleeve 1 of the Aesculap star unit H against

the spring pressure in the direction of the arrow. ► Push the Aesculap star unit H onto adapter 2 of the S4C drill guide F/G. When doing so, ensure that the pin of the adapter 3 engages in the recess on the star unit. ► Release locking sleeve 1.

Brainlab instrument calibration matrix version 4, see Brainlab user manual. When doing so, ensure that the centering tool for navigated drill guide P/Q is removed. ► To ensure that the camera has an unrestricted view of the reflective marker spheres, loosen knob 6 on the S4C handle of the S4C drill guide F/G and rotate Aesculap star unit H to the desired position, see Fig. 2. ► Once the desired position is reached, tighten knob 6 again. ► Adjust the center punch depth by turning the depth stop 5 on the S4C drill guide F/G. The maximum depth is 6 mm. ► Insert S4C centering tool P/Q into S4C drill guide F/G. ► Check the pre-set center punch depth with a caliper (e.g. AA845R). ► To open the cortical bone, press S4C centering tool to the preset depth under control with the Brainlab navigation system. 2.3.2

Drilling holes for the S4C screws

DANGER Risk of injury from an incorrectly placed hole or a hole that is too deep! ► Do not sharpen the drill, as this would cause imprecise or incorrect readings on the depth gauge. ► Replace blunt drills with new ones. The drill is applied with a S4C drill guide and drilled in either manually with the drill handle (FJ839R) or with a motor system with the Aesculap Intrahandpiece (e.g. GD450R/GD456R). Assembling the drill and drill handle (for manual drilling only) DANGER Risk of damage to the spinal cord, nerve roots, adjacent intervertebral space or soft tissue through incorrect drilling! ► Use only the correct S4C drill guides to drill holes. Insert drill only with the correct drill guide. ► Before drilling, the pre-set drill length must be checked with a caliper (e.g. AA845R, Caspar instrument for anterior cervical fusion).

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en DANGER Injury to spinal cord and nerve roots caused by application of a drill that is too long! ► Use the X-ray image to select an appropriate drill length prior to the operation. ► Drill may only be aligned and inserted under radiographic control and/or with the aid of a navigation system. ► Select a drill of a length equivalent to the intended drill hole depth. ► Insert drill in the drill handle (FJ839R), see Fig. 3. ► Retract and hold locking sleeve against the spring pressure in the direc-

tion of the arrow.

Note The drill Ø 2.4 mm (FW051SU) and Ø 2.9 mm (FW052SU) must not be used with S4C navigated drill guide F/G. ► For mounting the reflective Brainlab marker spheres 4 onto Aesculap

star unit H, see Brainlab user manual. ► Retract and hold locking sleeve 1 of the Aesculap star unit H against

the spring pressure in the direction of the arrow. ► Aesculap star unit H is then pushed onto adapter 2 of the S4C drill

guide F/G. When doing so, ensure that the pin 3 of the adapter engages in the recess on the star unit. ► Release locking sleeve 1.

► Push the drill into the receptacle of the drill handle as far as it will go ► Lightly rotate the drill and release locking sleeve.

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The drill engages audibly.

F/G

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Fig. 3

R/S

Assembling the drill

DANGER Risk of injury and/or damage to the drill if the drill rotation speed is too high! ► Use the lowest drilling speed possible, so that you can control the drilling depth. ► Do not bend the drill during the drilling process. 2.3.3

Drilling holes for S4C screws Ø 3.5 mm/4.0 mm

WARNING Risk of injury to patients due to incorrect navigation! ► Observe the combination specifications For controlled drilling of the holes for S4C screws Ø 3.5 mm with drill Ø 2.4 mm R (FW666SU), the S4C navigated drill guide Ø 3.5 mm F (FW664R) must always be used. For controlled drilling of the holes for S4C screws Ø 4.0 mm with drill Ø 2.9 mm S (FW667SU), the S4C navigated drill guide Ø 4.0 mm G (FW665R) must always be used. S4C navigated drill guide G and drill Ø 2.9 mm S have a purple marking on the shaft for the self-tapping S4C screws Ø 4.0 mm screws, see Fig. 4.

S G

Fig. 4

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Purple marking on S4C navigated drill guide and drill

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Mounting the Aesculap star unit on S4C drill guide FW664R/FW665R

► Prior to each use, check and/or validate the instrument with the

Brainlab instrument calibration matrix version 4, see Brainlab user manual. When doing so, ensure that the drill R/S is removed. ► To ensure that the camera has an unrestricted view of the reflective marker spheres, loosen knob 6 on the handle of the S4C drill guide F/G and rotate Aesculap star unit H to the desired position, see Fig. 2. ► Once the desired position is reached, tighten knob 6 again. ► Adjust the drill depth by turning the depth stop 5 on the S4C drill guide F/G. ► The scale is in mm. Each half turn on the depth stop moves a distance of 0.5 mm. ► Insert the drill with mounted handle or Intra-handpiece into S4C drill guide F/G. ► Before drilling, the pre-set drill length must be checked with a caliper (e.g. AA845R, Caspar instrument for anterior cervical fusion). ► Drill to the pre-set depth under control with the Brainlab navigation system.

en 2.3.4 Tapping (optional) S4C screws are self-tapping screws. However, if the bone quality is found to be hard during the operation, the surgeon can also pre-tap the thread with the S4C tapper. ► For tapping the drill holes for screws Ø 3.5 mm with navigation, use the S4C navigated tapper A. ► For tapping the drill holes for screws Ø 4 mm, use the standard tapper without navigation (FW047R), see TA011984. DANGER Risk of tissue trauma when using the S4C tapper (A) and damage to bone thread! ► Prior to using the S4C tapper, ensure that the moveable sleeve of the tapper retracts correctly. ► For mounting the reflective Brainlab marker spheres 4 onto the refer-

ence star unit B (pre-calibrated), see Brainlab user manual. ► Push the reference star unit onto the shaft 7 of the S4C tapper (Tap) A.

Ensure that the star unit is securely fitted onto the shaft of the S4C tapper (Tap). Note The star unit can be rotated on the shaft of the S4C tapper (Tap). ► Retract and hold locking sleeve 8 against the spring pressure. ► Push the S4C handle FW067R/FW165R onto the shaft of the S4C

tapper A. ► Release locking sleeve 8, see Fig. 6. Check that the S4C handle is engaged. B

A B

Fig. 6

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Position S4C screw under navigation and temporarily fix it in place

DANGER Risk of injury to the patient! ► Use S4C screwdriver only with reference star unit ML for manual calibration. ► If you change screws, perform the calibration again. ► To position S4C screws Ø 3.5 mm and Ø 4 mm with navigation, use S4C

navigated screwdriver D. ► For mounting the reflective Brainlab marker spheres 4 onto the refer-

ence star unit ML E, see Brainlab user manual. ► Push the reference star unit ML E onto the shaft 10 of the S4C

crewdriver D. Ensure that the star unit is securely fitted onto the shaft of the S4C screwdriver. Note The star unit can be rotated on the shaft of the S4C screwdriver. ► Retract and hold locking sleeve 8 against the spring pressure. ► Push the S4C handle FW067R/FW165R onto the shaft of the

S4C screwdriver D. ► Release locking sleeve 8, see Fig. 8. ► Check that the S4C handle is engaged.

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2.3.5

Fig. 8

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Mounting the reference star unit (“pre-calibrated”) and S4C handle onto the S4C tapper

WARNING Risk of injury to the patient! ► Before use, ensure that the selected instrument has been correctly assembled. ► Ensure that the arrow on the underside of the reference star unit (pre-calibrated) is pointing to the tip of the tool.

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Mounting the reference star unit (“calibration with ICM 4”) and S4C handle (FW067R or FW165R) onto the S4C screwdriver

Note The S4C screwdriver is fitted with a self-retaining function to prevent the S4C screw from falling out when it is passed to the surgeon. ► Retract and hold the holding sleeve 12 on the S4C screwdriver D, see

Fig. 9. ► Insert the tip of the S4C screwdriver D fully into the hexagon of the screw 11. ► Release the holding sleeve 12. Ensure that the screw 11 is securely in place on the S4C screwdriver D and that the polyaxiality of the screw 11 is blocked.

► Prior to each use, check and/or validate the instrument with the

Brainlab instrument calibration matrix version 4, see Brainlab user manual. ► To tap the thread, hold the reference star unit B at the planned inden-

tations with one hand, and with the other hand screw in S4C thandle C slowly and steadily under control with the Brainlab navigation system, until the required depth is reached. ► Use the scale behind the retractable sleeve of the S4C tapper to read the depth during the tapping process,see Fig. 7.

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Fig. 9

Pick up the S4C screw with S4C screwdriver

A

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Tapper with readable thread depth

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en DANGER Risk of injury to the patient! ► Before use, ensure that the selected instrument has been correctly assembled. Ensure that the arrow on the underside of the reference star unit ML is pointing to the tip of the tool. ► Prior to using the instrument with the correctly held screw, perform

manual calibration with the Brainlab instrument calibration matrix version 4, see Brainlab user manual. ► Screw in the screw under control with the Brainlab navigation system. When doing so, hold reference star unit ML at the planned indentations with one hand, and turn the S4C handle C to screw in the screw 11 with the other hand. 2.3.6

1 2 3

H

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4 13

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Smooth-shaft screw instruments

WARNING Risk of injury to patients due to incorrect navigation! ► Observe the combination specifications Instruments for smooth-shaft screws are marked with a light-blue ring. They are used to center punch, drill and tap holes for smooth-shaft screws Ø 4 mm. DANGER Serious complications for the patient can be caused by incorrect positioning of instruments or implants! ► Carry out operative steps with radiographic visualization. ► When removing the smooth-shaft screw awl (FW085R) and during the further operating steps, ensure that the S4C navigated smoothshaft screw guide sleeve remains securely fixed in place. ► Ensure that the window on the S4C navigated smooth-shaft screw guide sleeve is closed during the preparation of the screw hole and while the screw is being inserted, see laser marking on the inner sleeve. ► Take care that no tissue gets caught when opening and closing the window on the S4C navigated smooth-shaft screw guide sleeve, after the screw has been put in place.

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Fig. 10 Mounting the Aesculap star unit on the S4C guide sleeve for smooth-shaft screws DANGER Risk of injury to patients due to incorrect navigation! ► Slide reduction sleeve into the Brainlab instrument calibration matrix version 4, until you hear an audible click. ► Prior to each use, check and/or validate the instrument with special

reduction sleeve J with the Brainlab instrument calibration matrix version 4, see Brainlab user manual. Ensure that all other instruments (centering tool, drill, tapper etc.) are removed for the instrument validation. J

► For mounting the reflective Brainlab marker spheres 4 onto Aesculap

star unit H, see Brainlab user manual. ► Retract and hold locking sleeve 1 against the spring pressure in the direction of the arrow. ► Aesculap star unit H is then pushed onto adapter 2. When doing so, ensure that the recess on the star unit is seated over the pin 3 of the adapter. ► Release locking sleeve 1.

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Fig. 11 Reduction sleeve for validation/verification with the Brainlab instrument calibration matrix version 4 ► To ensure that the camera has an unrestricted view of the reflective

marker spheres, loosen knob 6 on the S4C handle of the S4C guide sleeve I and rotate Aesculap star unit H to the desired position, see Fig. 10. ► Once the desired position is reached, tighten knob 6 again. ► Place S4C guide sleeve I for smoothshank screws in the operating field. When doing so, ensure that the window of the guide sleeve is closed during the preparation and insertion of the screw with the guide sleeve, see laser marking on the inner sleeve 13. ► Center punch the cortical layer of the vertebral body with the smoothshank screw aw (FW085R), see TA011984 and Operating Technique (O34202). ► If necessary, insert the awl into the inner sleeve 13 and center punch the bone as far as the stop-position. The stop-position is indicated with a marking on the awl. ► Remove the awl from the operating field. ► Insert the smooth-shaft screw drill (FW086SU) 14 with mounted handle (FJ839R) or Intra-handpiece into the inner sleeve 13. ► Before drilling, the pre-set drill length must be checked with a caliper (e.g. AA845R, Caspar instrument for anterior cervical fusion).

en ► Under control with the Brainlab navigation system, drill a hole in the

bone until the adjustable stop-position is reached. For further information on drilling, see instructions for use of the S4 Cervical instruments (TA011984) and Operating Technique (O34202). ► Remove the drill from the operating field. ► To prepare the drill holes for the screws, tap the thread with the smooth-shaft screw tapper (FW087R). ► Insert the smooth-shaft screw tapper into the inner sleeve and slowly and steadily tap in until the desired depth is reached. When doing so, read the thread depth on the tapper scale. ► Remove smooth-shaft screw tapper from the operating field. Note If the S4C screw is to be inserted under navigation with the S4C screwdriver FW656R using the guide sleeve I, remove the Aesculap star unit on the S4C guide sleeve for smoothshank screws. DANGER Risk of injury to patients due to incorrect navigation! ► The navigated S4C screwdriver FW656R or other S4C screwdrivers are only intended for navigation in the non-navigated S4C guide sleeve FW658R. ► For navigating the S4C screwdriver FW656R, see section on positioning the S4C screw under navigation and temporarily fixing it in place. DANGER Risk of injury to the patient through freely rotating screws! ► Do not screw in screw so far that the screw head comes into contact with the S4C guide sleeve. Note Use the navigated S4C screwdriver FW656R only with non-navigated S4C guide sleeve FW658R. ► Navigate S4C screwdriver, see Position S4C screw under navigation and

temporarily fix it in place. ► Insert the screw through the S4C guide sleeve but do not screw it in completely (smooth shaft must remain free). Remove S4C screwdriver D from the operating field. ► Remove instrument from the screw: – Turn the blue inner sleeve 13 and open the window on the S4C guide sleeve. – Carefully push away S4C guide sleeve I laterally from the screw. – Remove S4C guidesleeve I from the operating field.

2.3.7

Instruments for Favored Angle screws

WARNING Risk of injury to patients due to incorrect navigation! ► Observe the combination specifications Favored Angle instruments are marked with a gold-colored ring. DANGER Serious complications for the patient can be caused by incorrect positioning of instruments or implants! ► Carry out operative steps with radiographic visualization. ► When removing the obturator (FJ983R) and during the further operating steps, ensure that the S4C guide sleeve remains securely fixed in place. Drilling holes for Favored Angle screws ► For mounting the reflective Brainlab marker spheres 4 onto Aesculap star unit H, see Brainlab user manual. ► Aesculap star unit H is mounted onto S4C navigated guide sleeve Ø 3.5/4.0 mm K. When doing so, retract and hold the locking sleeve 1 against the spring pressure in the direction of the arrow. ► Push the Aesculap star unit H onto adapter 2 of the S4C guide sleeve K. When doing so, ensure that the recess is seated over the pin 3 of the adapter. ► Release locking sleeve 1.

K

1 2 3

H

4 15

K

L

16

6 Fig. 12 Mounting the Aesculap star unit onto the S4C guide sleeve; Inserting the S4C inner drill sleeve ► Prior to each use, check and/or validate the instrument with the

Brainlab instrument calibration matrix version 4, see Brainlab user manual. Ensure that the inner drill sleeve L is mounted prior to this check. ► To ensure that the camera has an unrestricted view of the reflective marker spheres, loosen knob 6 on the S4C handle of the S4C guide sleeve K and rotate Aesculap star unit H to the desired position, see Fig. 12. ► Once the desired position is reached, tighten knob 6 again. ► Remove inner drill sleeve L from the S4C guide sleeve K. ► Insert obturator (FJ983R) into the inner sleeve 15 of the S4C guide sleeve K. ► The obturator engages in the inner sleeve and can still be rotated. ► Bring S4C guide sleeve K with mounted obturator into the operating field through the stab incision and position it in place. ► Press the button 16 on the obturator (FJ983R) and withdraw the obturator from the inner sleeve 15. 9

en ► If necessary, slide Apfelbaum trocar (FJ984R) into the inner sleeve 15

and insert into the bone to center punch the screw entry point. ► Remove the trocar from the operating field. ► Slide the inner drill sleeve L onto the inner sleeve 15. ► The inner drill sleeve engages on the inner sleeve and can still be rotated, see Fig. 12. ► Insert drill for Favored Angle screws (FW088SU)with mounted handle (FJ839R) or Intra-handpiece into the inner drill sleeve L. ► Drill to the pre-set depth under control with the Brainlab navigation system. The drill depth can be read on the scale on the inner drill sleeve L. Note So as not to lose the entry opening, it can be helpful to keep the drill in the drill hole, press the button 16 on the inner drill sleeve L and push down the guide sleeve until it reaches the stop on the bone surface. Then remove the drill and inner drill sleeve L from the S4C guide sleeve K. ► Press the button 16 and remove the inner drill sleeve L from the inner

sleeve 15. 4C screws are self-tapping screws. However, if the bone quality is found S to be hard during the operation, the surgeon can also pre-tap the thread with the S4C tapper. ► To prepare screw holes, insert the Favored Angle tapper Ø 4 mm (FW089R) into the inner sleeve 15 and tap. The drill depth can be read on the scale on the tapper (Tap). ► Turn the tapper (Tap) counterclockwise until it exits the bone. Note So as not to lose the entry opening, it can be helpful to turn the tapper (Tap) counterclockwise until it almost exits the bone. Then turn the inner sleeve 15 counterclockwise and at the same time push down the S4C guide sleeve K until it reaches the stop on the bone surface. Then unscrew the Favored Angle tapper Ø 4 mm (FW089R) completely from the bone and remove it together with the inner sleeve 15 from the S4C guide sleeve K. Inserting the screw ► Ensure that the inner sleeve 15 has been removed from the S4C guide sleeve K by turning it counterclockwise. ► Pick up a suitable Favored Angle screw Ø 4.0 mm with the self-retaining S4C screwdriver (FW069R/FW132R). When doing so, retract and hold the black holding sleeve against the spring pressure. Note The self-retaining function of the instrument prevents the screw from falling out of the S4C screwdriver when it is being passed to the operating surgeon. ► Press the working end of the S4C screwdriver fully into the hexagon of

the screw 11. ► Release the black holding sleeve. ► Screw in the screw under control with the Brainlab navigation system. ► Tighten the screw. When doing so, work through the S4C guide sleeve.Activate the black holding sleeve and release the S4C screwdriver from the screw. ► Remove S4C guide sleeve S4C from the operating field.

10

2.3.8

Standard screw (Ø 3.5 mm) instrumentation with Favored Angle instruments

WARNING Risk of injury to patients due to incorrect navigation! ► Observe the combination specifications To insert standard screws Ø 3.5 mm with the Favored Angle instruments, the instruments M, N and O must also be used. These instruments are marked with a black ring. DANGER Serious complications for the patient can be caused by incorrect positioning of instruments or implants! ► Carry out operative steps with radiographic visualization. ► When removing the obturator (FJ983R) and during the further operating steps, ensure that the guide sleeve remains securely fixed in place. ► For mounting the reflective Brainlab marker spheres 4 onto Aesculap

star unit H, see Brainlab user manual. ► Aesculap star unit H is mounted onto S4C navigated guide sleeve

Ø 3.5/4.0 mm K. When doing so, retract and hold the securing sleeve 1 against the spring pressure in the direction of the arrow. ► Aesculap star unit H is then pushed onto adapter 2 of the S4C guide sleeve K. When doing so, ensure that the recess is seated over the pin 3 of the adapter. ► Release locking sleeve 1.

1 2 3

K

H

H

K

4 15

M

16

6 Fig. 13 Mounting the Aesculap star unit onto the S4C guide sleeve; Inserting the S4C drill guide ► Prior to each use, check and/or validate the instrument with the

Brainlab instrument calibration matrix version 4, see Brainlab user manual. Ensure that the inner drill sleeve M is mounted prior to this check. ► To ensure that the camera has an unrestricted view of the reflective marker spheres, loosen knob 6 on the S4C handle of the S4C guide sleeve K and rotate Aesculap star unit H to the desired position, see Fig. 13. ► Once the desired position is reached, tighten knob 6 again. ► Remove inner drill sleeve M from the guide sleeve K. ► Insert obturator (FJ983R) into the inner sleeve 15 of the S4C guide sleeve K. The obturator engages in the inner sleeve and can still be rotated. ► Bring S4C guide sleeve K with mounted obturator into the operating field through the stab incision and position it in place.

en ► Press the button 16 on the obturator (FJ983R) and withdraw the obtu-

rator from the inner sleeve 15. ► If necessary, slide Apfelbaum trocar (FJ984R) into the inner sleeve 15 and insert into the bone to center punch the screw entry point. ► Remove the trocar from the operating field. ► Slide the inner drill sleeve M onto the inner sleeve 15. The inner guide sleeve engages on the inner sleeve and can still be rotated, see Fig. 13. ► Insert drill Ø 2.4 mm N with mounted handle (FJ839R) or Intra-handpiece into the inner drill sleeve M. ► Drill to the pre-set depth under control with the Brainlab navigation system. The drill depth can be read on the scale on the inner drill sleeve M. Note So as not to lose the entry opening, it can be helpful to keep the drill in the drill hole, press the button 16 on the inner drill sleeve M and push down the guide sleeve until it reaches the stop on the bone surface. Then remove the drill and inner drill sleeve M from the S4C guide sleeve K. ► Press the button 16 and remove the inner drill sleeve M from the inner

sleeve 15. S4C screws are self-tapping screws. However, if the bone quality is found to be hard during the operation, the surgeon can also pre-tap the thread with the S4C tapper. ► To prepare screw holes, insert the C1/C2 tapper (Tap) Ø 3.5 mm O into the inner sleeve 15 and tap. The drill depth can be read on the scale on the tapper (Tap). ► Turn the tapper (Tap) O counterclockwise until it exits the bone. Note So as not to lose the entry opening, it can be helpful to turn the tapper (Tap) counterclockwise until it almost exits the bone. Then turn the inner sleeve 15 counterclockwise and at the same time push down the S4C guide sleeve K until it reaches the stop on the bone surface. Then unscrew the tapper O completely from the bone and remove it together with the inner sleeve 15 from the S4C guide sleeve K. Inserting the screw ► Ensure that the inner sleeve 15 has been removed from the S4C guide sleeve K by turning it counterclockwise. ► Pick up a suitable standard screw Ø 3.5 mm with the self-retaining S4C screwdriver (FW069R/FW132R). When doing so, retract and hold the black holding sleeve against the spring pressure. Note The self-retaining function of the instrument prevents the screw from falling out of the S4C screwdriver when it is being passed to the operating surgeon. ► Press the working end of the S4C screwdriver fully into the hexagon of

the screw 11. ► Release the black holding sleeve. ► Screw in the screw under control with the Brainlab navigation system. ► Tighten the screw. When doing so, work through the S4C guide sleeve. ► Activate the black holding sleeve and release the S4C screwdriver from

the screw. ► Remove S4C guide sleeve and S4C screwdriver from the operating field.

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".

11

en 3.3

Single-use products

Art. no.

Designation

FW086SU

Drill Ø 2.9 mm for smooth-shaft screws

FW088SU

Favored Angle screw drill Ø 2.9 mm for Ø 4 mm screws

FW662SU

S4 C1/C2 drill Ø 2.4 mm

FW666SU

Drill, Ø 2.4 mm

FW667SU

Drill, Ø 2.9 mm

3.7

3.7.1 S4C navigated tapper Ø 3.5 mm FW655R ► Loosen nut 19 and unscrew from the sleeve 17. ► Remove sleeve 17 in the direction of the arrow. Note Spring 18 is fixed on shaft. A

► 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

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. ► Disassemble the product prior to cleaning. ► Open up product with hinges. ► Open all valves/faucets.

18

17

19

Fig. 14 Disassembling the S4C tapper (Tap) 3.7.2 S4C navigated screwdriver FW656R ► Retract and hold green holding sleeve 22 against the spring pressure. ► Unscrew screw sleeve 20 at the working end of the S4C screwdriver and remove from the shaft. ► Release the green holding sleeve 22. ► Push the green holding sleeve 22 with the retaining tongues in the direction of the instrument's working end and remove from the screwdriver shaft.

Preparations at the place of use

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

Disassembly

20

21

23

22

D Fig. 15 Disassembling the S4C screwdriver S4C navigated drill sleeve Ø 3.5 mm (FW664R)/Ø 4.0 mm (FW665R) ► Turn guide sleeve 24 clockwise and remove. Be aware that it is a lefthanded thread. ► Loosen knob 25 counterclockwise, unscrew and remove from the handle by pulling in the direction of the arrow. 3.7.3

24 F/G 25

Fig. 16 Disassembling the S4C drill guide 3.7.4 S4C navigated guide sleeve for smooth-shaft screws, FW658R ► Turn inner sleeve 26 to the "remove" position and remove from the outer sleeve in the direction of the arrow. ► Loosen knob 25 counterclockwise, unscrew and remove from the handle by pulling in the direction of the arrow.

26 I 25

Fig. 17 Disassembling the guide sleeve for smoothshank screws

12

en 3.7.5 S4C navigated guide sleeve Ø 3.5 mm/4.0 mm FW660R ► Loosen inner sleeve 27 counterclockwise, unscrew and remove from the handle by pulling in the direction of the arrow. ► Loosen knob 25 counterclockwise, unscrew and remove from the handle by pulling in the direction of the arrow. K

27 25

Fig. 18 Disassembling the guide sleeve Ø 3.5 mm/4.0 mm

3.8

Cleaning/Disinfection

3.8.1

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. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. Note For cleaning and disinfecting the reference star unit (pre-calibrated) and the reference star unit ML (calibration with ICM4), see Brainlab user manual. 3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush: 30 mm/Ø: 4.5 mm, e.g. TA011944 and cleaning

Chapter Manual cleaning/disinfection and subsection:

■ FW655R to FW657R ■ FW663R ■ FW688R to FW689R

brush: 20 mm/Ø:2.5 mm, e.g. TE654202 and cleaning brush: 50 mm/Ø: 10 mm, e.g. TA007747

■ Disposable syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable hinges, ensure that these

■ Chapter Manual cleaning with immersion disinfection

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

■ Cleaning brush: 30 mm/Ø: 4.5 mm, e.g. TA011944 and cleaning

■ FJ985R ■ FW067R ■ FW165R ■ FW652R ■ FW658R ■ FW660R to FW661R ■ FW664R to FW665R

■ Disposable syringe 20 ml ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable hinges, ensure that these

brush: 20 mm/Ø:2.5 mm, e.g. TE654202 and cleaning brush: 50 mm/Ø: 10 mm, e.g. TA011327

Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

are in an open position and, if applicable, move the hinge while cleaning.

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

13

en Validated procedure

Specific requirements

Mechanical alkaline cleaning and thermal disinfection

■ Connect components with lumens and channels directly to the rins- Chapter Mechanical cleaning/disinfection and

■ FW657R ■ FW663R ■ FW688R–FW689R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ FW652R ■ FW655R–FW656R ■ FW658R ■ FW660R ■ FW664R–FW665R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FW067R ■ FW165R ■ FJ985R ■ FW661R

14

ing port of the injector carriage.

Reference subsection:

■ To flush the product: Use a flushing nozzle or flushing sleeve. ■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open.

■ Chapter Mechanical alkaline cleaning and

■ Cleaning brush: 30 mm/Ø: 4.5 mm, e.g. TA011944 and cleaning

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

brush: 20 mm/Ø:2.5 mm, e.g. TE654202 and cleaning brush: 50 mm/Ø: 10 mm, e.g. TA007747

thermal disinfecting

■ Chapter Manual pre-cleaning with a brush ■ Disposable syringe 20 ml ■ Chapter Mechanical alkaline cleaning and thermal disinfecting ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ FW664R, FW665R, FW658R, FW660R: To flush the product: Use a flushing nozzle or flushing sleeve.

■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open. ■ Cleaning brush: 30 mm/Ø: 4.5 mm, e.g. TA011944 and cleaning brush: 20 mm/Ø:2.5 mm, e.g. TE654202 and cleaning brush: 50 mm/Ø: 10 mm, e.g. TA007747

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

■ Chapter Manual pre-cleaning with ultrasound and brush ■ Disposable syringe 20 ml ■ Chapter Mechanical alkaline cleaning and ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ To flush the product: Use a flushing nozzle or flushing sleeve. ■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open.

thermal disinfecting

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 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.

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.

15

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.

16

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.

17

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

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.

18