Ennovate Cervical Navigated instruments

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Aesculap® Ennovate® Cervical Navigated instruments Legend Ennovate Cervical - Navigation supplement 1 Ennovate Cervical cortical punch for universal drill guide ∅ 3.5 mm / 3.6 mm screws (SZ059R) 2 Ennovate Cervical cortical punch for universal drill guide ∅ 4.0 mm screws (SZ060R) 3 Ennovate Cervical cortical punch for universal drill guide ∅ 4.5 mm screws (SZ061R) 5 Aesculap navigation adapter with 4 marker spheres (SZ091R) 6 Aesculap universal navigation adapter L-shape (SZ093R) 7 Aesculap universal navigation clamp (SZ096R) consisting of: 7a Brainlab instrument adapter softgrip clamp size L (55113) 7b Brainlab instrument adapter extension 50 mm (55016) 7c Brainlab instrument adapter array size ML (41799) 8 Brainlab instrument adapter array size L (41801) 9 Ennovate Cervical navigation handle straight (SZ007R) 10 Ennovate Cervical assembly tool for navigation handle (SZ095R) The relative size of the instruments does not necessarily reflect their size in reality. The depictions in this document are schematic representations only and may deviate from the actual product.

Contents 1. 1.1 1.2 2. 2.1 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 3. 3.1 3.2 3.2.1 3.2.2 3.3 3.3.1 3.3.2 3.3.3 3.4 3.4.1 3.4.2 3.5

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About this document... Scope... Safety messages... Clinical use... Components required for use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Application... Safe application... Set up navigation... Mount the navigation adapter on the instruments... Manual calibration of Ennovate Cervical instruments... Prepare hole with the navigated drill guide... Prepare universal drill guide... Open Cortex with navigation... Drill hole with navigation... Prepare hole with bone probes... Prepare bone probe... Prepare channel with bone probe... Confirm depth and use K-wire for guidance...

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3.6 3.6.1 3.6.2 3.7 3.7.1 3.7.2 3.8 3.8.1 3.8.2 3.8.3 4. 4.1 4.2 4.3 4.4 4.5 4.6 4.6.1 4.6.2 4.7 4.7.1 4.7.2 4.8 4.8.1 4.8.2 4.9 4.9.1 4.10 4.10.1 4.10.2 4.11 4.11.1 4.11.2 4.12 4.12.1 4.13 4.14 4.15 5. 6.

Cut thread with tap using navigation (optional)... 7 Prepare taps... 7 Perform navigated tapping... 8 Perform navigated screw insertion... 8 Prepare Ennovate Cervical screwdriver SZ063R... 8 Perform navigated screw insertion... 8 Perform C1/C2 transarticular screw placement with navigation 8 Prepare the Ennovate Cervical all-in-one guide SZ131R... 8 Fix clamp as described in Brainlab user guides... 9 Insert all-in-one guide, drill, tap and insert screw... 9 Validated reprocessing procedure... 9 General safety instructions... 9 General information... 9 Reusable products... 10 Preparations at the place of use... 10 Preparing for cleaning... 10 Disassembly... 10 Aesculap universal navigation clamp SZ096R... 10 Aesculap navigation adapter SZ091R... 10 Cleaning/Disinfection... 10 Product-specific safety information on the reprocessing method... 10 Validated cleaning and disinfection procedure... 11 Manual cleaning/disinfection... 12 Manual cleaning with immersion disinfection... 12 Manual cleaning with ultrasound and immersion disinfection 13 Mechanical cleaning/disinfection... 14 Mechanical alkaline cleaning and thermal disinfecting... 14 Mechanical cleaning/disinfection with manual pre-cleaning. 15 Manual pre-cleaning with a brush... 15 Mechanical alkaline cleaning and thermal disinfecting... 16 Inspection... 16 Visual inspection... 16 Functional test... 16 Assembly... 17 Aesculap universal navigation clamp SZ096R... 17 Packaging... 17 Steam sterilization... 17 Storage... 17 Technical service... 17 Disposal... 17

en 1.

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 to the Ennovate Cervical navigated instruments listed in the legend and may only be used with the Brainlab navigation system. 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

Components required for use

All instruments listed in the legend are required for use. Additionally, instruments from the Ennovate Cervical Basic set, the Ennovate Cervical C1/C2 set or the Ennovate Cervical MIS set are required for use.

2.2

Areas of use and limitations of use

2.2.1 Intended use Ennovate Cervical navigated instruments are used for the navigated implantation of Ennovate Cervical system implants. The indications and contraindications are described in the instruction for use of the Ennovate Cervical implants (TA015777). 2.2.2 Indications Note The manufacturer is not responsible for any use of the product against the specified indications and/or the described applications. For indications, see Chapter 2.2.1. 2.2.3 Contraindications For contraindications, see Chapter 2.2.1.

2.3

Safety information

2.3.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user. Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product. 2.3.2

Product

Product-specific safety information All the risks related to the implantation/handling of the instruments are described in detail in the respective instructions for use. ► Thoroughly read the instructions for use before performing navigated surgery. These instructions for use apply to the Ennovate Cervical navigated instruments listed in the legend and may only be used with the Brainlab navigation system. The surgical technique and its related risks are described in detail in following documents: Art. no.

Designation

TA015777

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

TA015763

IFU ENNOVATE CERVICAL BASIC INSTRUMENTS

TA015761

IFU ENNOVATE CERVICAL C1/C2 INSTRUMENTS

TA015766

IFU ENNOVATE CERVICAL MIS INSTRUMENTS

TA015755

IFU ENNOVATE CERVICAL TRAYS

O03202

ENNOVATE CERVICAL NAVIGATION - SURGICAL TECHNIQUE

O03302

ENNOVATE CERVICAL MIS - SURGICAL TECHNIQUE

For navigated Aesculap instruments included in other sets please refer to the corresponding instructions for use. For more information on the safe handling of Brainlab instruments as well as on the Navigation Software Spine & Trauma 3D, refer to the relevant Brainlab instrument and software user guides. Visit https://www.brainlab.com to access online user guides or to contact the Brainlab customer support.

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en Aesculap and Brainlab accept absolutely no responsibility if instruments other than those named below are used. Follow the combinations described in this document. ► Only combine Aesculap products (and Brainlab instruments listed in this document) with each other. ► Only use Aesculap Ennovate instruments and accessories. ► Observe the graphic/packing template when storing the instruments. ► Use the product only in applications according to its intended use, see Chapter 2.2.1. Instruments can fall in situ or on the floor! Handles can loosen during use! ► Check the seating of the coupling handles on the instruments for tightness. Injury of spinal cord, nerve roots and blood vessels due to piercing of the cortex in case of incorrect application! ► Only carry out alignment and insertion of the instruments and polyaxial screws under radiographic control or with the aid of a navigation system. 2.3.3

Sterility

Non-sterile, reusable products Art. no.

Designation

SZ059R

Ennovate Cervical cortical punch for universal drill guide ∅ 3.5 mm / 3.6 mm screws

SZ060R

Ennovate Cervical cortical punch for universal drill guide ∅ 4.0 mm screws

SZ061R

Ennovate Cervical cortical punch for universal drill guide ∅ 4.5 mm screws

SZ091R

Aesculap navigation adapter with 4 marker spheres

SZ093R

Aesculap universal navigation adapter L-shape

SZ007R

Ennovate Cervical navigation handle straight

SZ095R

Ennovate Cervical assembly tool for navigation handle

SZ096R

Aesculap universal navigation clamp

► Inspect the new product after removing its transport packaging and

3.

Application

3.1

Safe application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or missing components. ► Always carry out a function test prior to each use of the product. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. WARNING Risk of injury to the patient 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 navigation adapter. ► Make sure that the navigation camera has an unrestricted view of the reflective marker spheres of the instruments. WARNING Risk of injury to the patient due to damaged instruments! Ennovate Cervical instruments are precise and can be easily damaged. ► Handle Ennovate Cervical instruments with the greatest of care. ► Make sure that the instruments used are not bent or damaged. Specifically check that navigation adapters, including pins, are not bent. ► 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 rev. 4. ► Do not repair or modify the instruments (e.g. sharpening of the tips). In case of malfunction send them to Aesculap Technical Service. WARNING Risk of injury to the patient due to incorrect navigation! ► Use navigated Ennovate Cervical instruments only with Brainlab disposable reflective marker spheres. ► For further information on the correct handling of the marker spheres, see the corresponding Brainlab user manual.

prior to first use to ensure it is in good working order.

3.2 The product is delivered in a non-sterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

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Set up navigation

WARNING Inaccurate navigation due to bent instruments! ► Once the instrument (e.g. probe, drill) is inserted in the bone, do not correct the axis anymore, as this may cause the instrument to bend and the navigation display to be inaccurate. If a correction of the axis is required, remove the instrument and insert it again.

en 3.2.1

► Prior to each use, calibrate and verify the accuracy of the navigated

Mount the navigation adapter on the instruments

WARNING Operation delay due to wrong adapter mounted on the instrument! ► Make sure to mount the correct adapter.

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instruments with the Brainlab instrument calibration matrix rev. 4, see Fig. 2. ► Select instruments from the first page of the Instrument Selection Software on the navigation platform. ► Follow the instructions on the screen to calibrate and verify the instrument with the Brainlab calibration matrix rev. 4. Once the instrument is calibrated, it will appear in the tab “Calibrated instruments”. Further information regarding calibration and verification of instruments with the Ennovate Cervical instruments and the Brainlab system can be found in the Brainlab user guide.

3.3

3.3.1

Fig. 1

Prepare universal drill guide 5

► To ensure a safe mounting of the Brainlab reflective marker spheres

onto the Aesculap navigation adapter 5 (SZ091R) and the Brainlab instrument adapter arrays 7c/8, please refer to the Brainlab user guides. ► Make sure to mount the correct adapter on each instrument. Refer to the descriptions in the following sections or to O03202 to see which adapter to use with each instrument. ► Proceed as follows to mount a navigation adapter 5/6 on any navigated instrument, see Fig. 1. – Retract and hold the locking sleeve c of the Aesculap navigation adapter 5/6 against the spring pressure in the direction of the arrow. – Push the Aesculap navigation adapter 5/6 onto the navigation pin a (if available) of the instrument. When doing so, make sure that the navigation pin a engages in the recess b on the navigation adapter. – Release locking sleeve c.

Prepare hole with the navigated drill guide

For this step, the universal drill guide OPEN/NAV SZ055R (see the instructions for use for Ennovate Cervical Basic instruments (TA015763)) or the MIS universal drill guide SZ143R (see the instructions for use for Ennovate Cervical MIS instruments (TA015766)) can be used.

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Fig. 3 ► Assemble the appropriate drill guide tube (pay attention to the color-

3.2.2

Manual calibration of Ennovate Cervical instruments

WARNING Risk of injury to the patient due to incorrect navigation! ► Make sure that the navigation adapter is properly fixed on the instruments. ► Make sure to perform a correct calibration of the instruments before each use. ► Make sure that each instrument is correctly assembled.

coding), set and control the desired drill depth, see TA015763 and TA015766. ► Mount the navigation adapter 5 (SZ091R) onto the universal drill guide a (SZ055R/SZ143R), see Chapter 3.2.1, see Fig. 3. ► Make sure that the drill or cortical punch are removed prior to calibration. ► Calibrate the drill guide SZ055R/SZ143R, see Chapter 3.2.2. ► To ensure that the camera has an unrestricted view of the reflective marker spheres, loosen knob b on the handle of the drill guide and rotate the navigation adapter 5 to the desired position. Once the desired position is reached, tighten the knob b again, see Fig. 3.

Fig. 2

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en 3.3.2 Open Cortex with navigation The cortical punches 1/2/3 (SZ059R/SZ060R/SZ061R) are marked with a color coded ring according to the screw head color.

3.3.3 Drill hole with navigation ► Refer to TA015763 for a detailed description of drilling and its related risks.

CAUTION Delay of surgery due to incorrect hole size! ► Check the color coding and laser marking to ensure the correct cortical punch is used.

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Fig. 6 ► Check that the depth stop of the guide is set at the intended drilling

Fig. 4 ► Place the reference array on the patient's spine as described in the

Brainlab user guide. ► Choose the appropriately sized cortical punch 1/2/3. ► Introduce the cortical punch 1/2/3 into the universal drill guide a

(SZ055R/SZ143R), see Fig. 4. ► To prevent soft tissue injury make sure that the tip of the cortical punch

is not coming out of the drill guide when approaching the bone. ► Position the punch together with the drill guide on the desired entry point and advance the punch into the bone until the stop is reached. Note The cortical punch has a positive stop in the drill guide and protrudes 6 mm (independently of the depth stop).

depth, select the drill and attach it to the handle a (SZ002R/SZ003R) or motor system, see TA015763 and TA015766. ► Leave the guide b (SZ055R/SZ143R) at the desired entry site and advance the drill c carefully to the predefined depth under trajectory control with the Brainlab navigation system until the stop is reached.

3.4

Prepare hole with bone probes

Alternatively, navigated pedicle preparation can be performed with straight bone probes. 3.4.1

Prepare bone probe

WARNING Risk of injury due to inaccurate navigation! ► Make sure to firmly tighten the Brainlab adapter soft grip clamp size L 7a on the hexagonal shaped area of the Aesculap bone probe.

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Fig. 7 The tip of the universal drill guide is navigated in real time. By default the navigation shows the instrument with a virtual line to help define the correct trajectory. ► Activate the screw planning feature on the navigation system to display a virtual screw at the tip of the universal drill guide. ► Remove the cortical punch.

► Select the appropriate Ennovate Cervical straight bone probe

(SZ022R/FW674R/SZ026R/SZ024R). ► Mount the reflective Brainlab marker spheres onto the Brainlab instru-

ment adapter array size ML 7c (41799). ► Assemble the universal navigation clamp 7 (SZ096R) (consisting of

Brainlab components 7a (55113), 7b (55016) and 7c (41799)) according to the Brainlab instrument user guide and as can be seen on the left side of the image, see Fig. 7.

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en ► Fix the universal navigation clamp 7 at the hexagonal shaped area of

► Attach the tap a to the navigation handle 9:

the bone probe a, as can be seen on the right side of the image, see Fig. 7. Make sure that the clamp is fully tightened. ► Calibrate the bone probe, see Chapter 3.2.2. For more information about safe mounting of the Brainlab components 7a/7b/7c and the reflective marker spheres please refer to the Brainlab user guides.

– Insert the hexagonally shaped portion of the tap shaft into the handle. – Tighten the handle to the shaft by inserting the assembly tool 10 to the distal end of the navigation handle 9 and turn the assembly tool 10 clockwise as shown on the left side of the image, see Fig. 9. The navigation handle 9 can be moved to the following positions by rotating the collar of the handle, shown on the right side of the image, see Fig. 9: ■ Forward (IN): for tapping ■ Locked (•): for blocking the ratchet ■ Reverse (OUT): for removing tap from the bone ► Calibrate the navigated tap, see Chapter 3.2.2.

3.4.2

Prepare channel with bone probe 7

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► Prepare the channel with the chosen bone probe a (see TA015763)

under control of the Brainlab navigation system.

3.5

Confirm depth and use K-wire for guidance

► Refer to TA015763 (the use of the K-wires is optional).

3.6

Cut thread with tap using navigation (optional)

3.6.1

Prepare taps

CAUTION Operation delay! ► Always tighten handle prior to calibration. ► Do not retighten the handle to the shaft after having performed the calibration.

Fig. 10 Alternatively to calibrating the tap with the Aesculap navigation adapter 5 (SZ091R), the tap can be calibrated by using the Aesculap universal navigation adapter L-shape 6 (SZ093R) together with the Brainlab components 8 (41801) and 7a (55113). ► Mount the universal navigation adapter L-shape 6 onto the navigation handle 9, see Fig. 10. ► Mount the Brainlab instrument adapter array size L 8 onto the Brainlab instrument adapter softgrip clamp size L 7a (55113) as described in the Brainlab user manual and as can be seen on the bottom of the image, see Fig. 10. ► Mount the softgrip clamp 7a onto the navigation adapter 6. ► Perform the calibration, see Chapter 3.2.2.

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Fig. 9 ► Mount the reflective marker spheres on the Aesculap navigation

adapter 5 (SZ091R). Mount the Aesculap navigation adapter 5 on the navigation handle 9 (SZ007R), see Chapter 3.2.1. ► Choose the correct tap a (SZ051R/SZ052R/SZ053R).

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en 3.6.2 Perform navigated tapping ► Follow all steps of tapping, see TA015763.

3.7.2

Perform navigated screw insertion

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The navigation adapter can be rotated on the handle. During tapping, one hand holds the handle while the other hand holds the navigation adapter to enable continuous visual access of the camera to the navigation adapter. ► To loosen the navigation handle 9 (SZ007R) from the tap: insert the assembly tool 10 (SZ095R) into the distal end of the navigation handle 9 and turn the assembly tool 10 counter-clockwise.

3.7

Perform navigated screw insertion

DANGER Risk of injury to the patient due to inaccurate navigation! ► Always repeat the calibration procedure when changing screws (even if using screws of the same dimensions). 3.7.1

Prepare Ennovate Cervical screwdriver SZ063R

► Insert the screw under control of the navigation system. Refer to

TA015763 for a detailed description of screw insertion and the risks related to it. The navigation adapter 5 can be rotated on the handle 9 to enable continuous visual access of the camera to the navigation adapter. ► During screw insertion, hold the handle 9 with one hand and the navigation adapter 5 with the other hand. ► To loosen the navigation handle 9 (SZ007R) from the screwdriver a (SZ063R) insert the assembly tool 10 into the distal end of the navigation handle and turn the assembly tool 10 counter-clockwise.

3.8

Perform C1/C2 transarticular screw placement with navigation

3.8.1

Prepare the Ennovate Cervical all-in-one guide SZ131R

CAUTION Operation delay! ► Always tighten the handle prior to the calibration. ► Do not retighten the handle to the shaft after having performed the calibration.

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Fig. 14 Fig. 12 ► Mount the reflective marker spheres onto the Aesculap navigation

adapter with 4 marker spheres 5 (SZ091R). ► Attach the Aesculap navigation adapter 5 to the navigation handle 9

(SZ007R), see Chapter 3.2.1. ► Attach the screwdriver a (SZ063R) to the navigation handle 9. The

screwdriver attachment to the handle is exactly the same as for the taps, see Fig. 12, see Chapter 3.6.1 ► Attach the screw to the screwdriver (see TA015763) and perform the calibration, see Chapter 3.2.2.

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► Mount the reflective marker spheres on the Aesculap navigation

adapter 5 (SZ091R). Attach the navigation adapter 5 to the all-in-one guide c (SZ131R), see Chapter 3.2.1. ► To ensure that the camera has an unrestricted view of the reflective marker spheres, loosen knob b on the handle of the navigated all-inone guide c and rotate the Aesculap navigation adapter 5 to the desired position. Once the desired position is reached, tighten knob b again. ► Insert the inner drill guide d (SZ134R) into the all-in one guide c. The inner drill guide locks automatically, see Fig. 14.

en ► Perform the calibration with the inserted inner drill guide d, see

Chapter 3.2.2. ► After calibration and verification of the all-in-one guide, remove the inner drill guide. Push the golden button a, as shown on the right side of the image (see Fig. 14) to release the locking and retract the inner drill guide. 3.8.2 Fix clamp as described in Brainlab user guides Due to difficulties of placing the clamp on C1 you may need to place it on C2. However, please be aware that due to the mobility of the subaxial spine this can lead to navigation inaccuracies. 3.8.3

4.

Validated reprocessing procedure

Note The validated reprocessing for the Brainlab instruments 7/8 is described in the latest version of the ''Cleaning, Disinfection and Sterilization Guide'', available on the Brainlab website (https://www.brainlab.com).

4.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

Insert all-in-one guide, drill, tap and insert screw 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.

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Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. 5

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.

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Note If there is no final sterilization, then a virucidal disinfectant must be used. Fig. 15 ► Insert the all-in-one guide a (SZ131R), see TA015761, see Fig. 15 (top).

With the navigated all-in-one guide a the following surgical steps can be performed under navigation guidance: stab incision, opening of the cortex, drilling, tapping and screw insertion, see Fig. 15 (bottom). ► Follow the steps described in TA015761 while keeping the Aesculap navigation adapter 5 (SZ091R) attached to the all-in-one guide a for navigation of all operative steps. 5

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Fig. 16 The tap b (SZ139R) and the screwdriver SZ140R can also be directly navigated by using the navigated handle 9 (SZ007R) through the non-navigated all-in-one guide a (SZ131R). ► Prepare the tap and the screwdriver, see Fig. 16, see Chapter 3.6.1, see Chapter 3.7.1. Follow the steps described in TA015761 while keeping the Aesculap navigation adapter 5 attached to the navigated handle 9.

Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

4.2

General information

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

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en ► Do not use metal cleaning brushes or other abrasives that would dam-

age the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKIBrochures", "Red brochure".

4.3

Reusable products

For the list of instruments that can be reused and must be sterilized prior to each use, see Chapter 2.3.3. There is no set maximum number of uses and reprocessing cycles for the product.. The life of the product is limited by damage, normal wear and tear, type and duration of use, as well as handling, storage and transport of the product. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

4.4

Preparations at the place of use

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

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

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

disinfection within 6 hours.

4.5

Preparing for cleaning

► Do not disassemble fixation screws which permanently connect the

various components. ► Disassemble the product prior to cleaning, see Chapter 4.6.

4.6

Disassembly

4.6.1

Aesculap universal navigation clamp SZ096R

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Fig. 17 ► Disassemble the universal navigation clamp 7 (SZ096R) (consisting of

Brainlab components 7a (55113), 7b (55016) and 7c (41799)) according to the Brainlab instrument user guide, see Fig. 17.

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4.6.2 Aesculap navigation adapter SZ091R ► Remove the reflective marker spheres before cleaning. Note Marker spheres are single use.

4.7

Cleaning/Disinfection

4.7.1

Product-specific safety information on the reprocessing method Danger to the patient! Navigation handle SZ007R must not be manually reprocessed. ► Reprocess navigation handle SZ007R 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 plastics and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of

in a wet condition. To prevent foaming and degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water ► Manually pre-clean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement). ► If the products can be securely fixed in machines or storage devices in such a way that they will be cleaned thoroughly, clean and disinfect them mechanically.

en 4.7.2 Validated cleaning and disinfection procedure Note The validated reprocessing for the Brainlab instruments 7/8 is described in the latest version of the ''Cleaning, Disinfection and Sterilization Guide'', available on the Brainlab website (https://www.brainlab.com). Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

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

Chapter Manual cleaning/disinfection and subsection:

■ SZ059R to SZ061R ■ SZ095R Manual cleaning with ultrasound and immersion disinfection

■ SZ091R ■ SZ093R

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

■ Chapter Manual cleaning with immersion disinfection Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfection

■ Place the product in a tray that is suitable for cleaning (avoiding rins- Chapter Mechanical cleaning/disinfection and

■ SZ059R to SZ061R ■ SZ095R

■ Place products in the tray with their hinges open. ■ SZ095R: Rinse the product under running water. Move the moving

ing blind spots).

subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

parts while doing so.

■ SZ095R: Connect components with lumens and channels directly to the rinsing port of the injector carriage. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ SZ007R ■ SZ091R ■ SZ093R

Chapter Mechanical cleaning/disinfection ■ Suitable cleaning brush with manual pre-cleaning and subsection: ■ 20 ml disposable syringe ■ Chapter Manual pre-cleaning with a brush ■ Place the product in a tray that is suitable for cleaning (avoiding rins■ Chapter Mechanical alkaline cleaning and ing blind spots).

■ Place products in the tray with their hinges open. ■ SZ007R: Connect components with lumens and channels directly to

thermal disinfecting

the rinsing port of the injector carriage.

11

en 4.8

Manual cleaning/disinfection

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

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

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

4.8.1

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 Chapter 4.7.2. 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 disin-

fectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Drain any remaining water fully.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time

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

12

Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Chapter 4.7.2.

en 4.8.2

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 Chapter 4.7.2. 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 Chapter 4.7.2.

13

en 4.9

Mechanical cleaning/disinfection

Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. 4.9.1 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

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

ing.

14

en 4.10 Mechanical cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. 4.10.1 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 Chapter 4.7.2. 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 disin-

fectant 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.

15

en 4.10.2 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

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

ing.

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

4.11.1 Visual inspection ► Make sure all dirt has been removed. Pay particular attention to e.g. fit-

ting surfaces, shanks, recesses, drilled grooves. ► For contaminated products: Repeat the cleaning and disinfection procedure. ► Check product for damage, e.g. insulation, corroded, loose, bent, broken, cracked, worn, heavily scratched or broken parts. ► Specifically check that navigation adapters, including their pins, are not bent. Check that pins on all navigated instruments are not bent. ► Check product for missing or faded labels and/or paint marks (e.g. color of handle, gold plating). ► Check products having long, narrow geometries (in particular rotating instruments) for deformations. ► Check cutting instruments for sharpness (example tips of punches). ► Check surfaces for variations in roughness. ► Check product for burrs that may damage tissue or surgical gloves. ► Check product for loose or missing parts. ► Check the cannulation of the instruments for continuity. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Chapter 5..

16

4.11.2 Functional test CAUTION Damage (metal seizure / friction corrosion) to the product caused by insufficient lubrication! ► Oil any moving parts (e. g. joints, pusher components and threaded rods) prior to the functional test using oil suitable for the applied sterilization process (e. g. STERILIT® I oil spray JG600 for steam sterilization or STERILIT® I drip-feed lubricator JG598). ► Assemble disassembled products, see Chapter 4.12. ► Check instruments having interfaces to other instruments for ease of

movement and compatibility. ► Check that the navigation adapters can be clipped onto the navigation

pin of the instruments (example on the navigation handle 9). ► Check that the product functions correctly. ► Check all moving parts (e.g. locks/interlocks, sliding parts, etc.) for full

and smooth movement. ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap

Technical Service, see Chapter 5..

en 4.12 Assembly 4.12.1 Aesculap universal navigation clamp SZ096R

7c 7b

7a

Fig. 18 ► Assemble the Aesculap universal navigation clamp 7 (SZ096R) (con-

sisting of Brainlab components 7a (55113), 7b (55016) and 7c (41799)) according to the Brainlab instrument user guide, see Fig. 18.

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

edges are covered.

5.

Technical service

CAUTION Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses. ► Do not modify the product. ► For service and repairs, please contact your national B. Braun/Aesculap agency. Service addresses Aesculap Technischer Service Am Aesculap-Platz 78532 Tuttlingen / Germany Phone: +49 7461 95-1601 Fax: +49 7461 16-2887 E-Mail: [email protected] Other service addresses can be obtained from the address indicated above.

6.

Disposal

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

► Package trays appropriately for the sterilization process (e.g. in

Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against contamination of the product during storage.

4.14 Steam sterilization ► Check to ensure that the sterilizing agent will come into contact with

all external and internal surfaces (e.g., by opening any valves and faucets). ► Validated sterilization process – Steam sterilization using fractional vacuum process – Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C / holding time 5 min ► If several devices are sterilized at the same time in the same steam sterilizer: Ensure that the maximum permitted load according to the manufacturers’ specifications is not exceeded.

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 Chapter 4..

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

a dry, dark, temperature-controlled area.

17