Quintex anterior cervical plate system - Instruments

A

B

E

F

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D

H

I

J

O

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en

Aesculap® Quintex® anterior cervical plate system - Instruments Legend A B C D E F G H I J K L M N O P Q

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 3.4 3.5 3.6 3.7 3.7.1 3.7.2 3.7.3 3.7.4 3.8 3.8.1

Plate bender SC420R Caliper SC421R Unsterile/sterile fixation pin SC410R/FJ833RS Instrument for fixation pins SC422R Adjustable single drill guide SC423R Adjustable double drill guide SC424R Single drill guide, fixed 14 mm SC425R Double drill guide, fixed 14 mm SC426R Cortical center punch SC428R Drill handle SC429R Drill SC430R Tap SC431R Screwdriver SC432R Screw extraction instrument SC433R Plate holding forceps SC434R Holding forceps FW076R Teardrop-shaped drill handle (optional) SC436R

Legend (figures in the text) 1 Quintex® plate 2 Bending wedge of the plate bender 3 Guide sleeve of the drill guide 4 Locking sleeve of the drill handle 5 Working end of the drill guide 6 Working end of the screwdriver 7 Screw head 8 Locking ring 9 Working end of the screw extraction instrument 10 Outer sleeve of the instrument for fixation pin 11 Outer sleeve of the cortical center punch 12 Knurled screw of the caliper

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

About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility...

3 3 3 3 3 3 3 3 3 3 3 3

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 3.14 3.15 3.16 4. 5.

Application... 3 Determining the Quintex® plate length... 3 Bending the Quintex® plate... 4 Positioning and temporary fixation of the Quintex® plate . . . 4 Preparing the holes for the Quintex® screws... 5 Tapping (optional)... 7 Inserting the screws... 8 Removing fixation pins... 9 Removing Quintex® implants... 9 Validated reprocessing procedure... 10 General safety instructions... 10 General information... 10 Single-use products... 10 Reusable products... 10 Preparations at the place of use... 10 Preparing for cleaning... 10 Disassembly... 11 Single drill guide SC423R and double drill guide SC424R... 11 Instrument for fixation pins SC422R... 11 Self-centering cortical center punch SC428R... 11 Caliper SC421R... 11 Cleaning/Disinfection... 11 Product-specific safety information on the reprocessing method... 11 Validated cleaning and disinfection procedure... 12 Manual cleaning/disinfection... 13 Manual cleaning with immersion disinfection... 13 Manual cleaning with ultrasound and immersion disinfection 14 Mechanical cleaning/disinfection... 15 Mechanical alkaline cleaning and thermal disinfecting... 15 Mechanical cleaning/disinfection with manual pre-cleaning. 16 Manual pre-cleaning with a brush... 16 Manual pre-cleaning with ultrasound and brush... 17 Mechanical alkaline cleaning and thermal disinfecting... 17 Inspection... 18 Visual inspection... 18 Functional test... 18 Assembly... 18 Single drill guide SC423R and double drill guide SC424R... 18 Instrument for fixation pins SC422R... 18 Self-centering cortical center punch SC428R... 18 Caliper SC421R... 18 Packaging... 18 Steam sterilization... 18 Storage... 18 Technical service... 19 Disposal... 19

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 for the following products: Quintex® anterior cervical plate system - 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: 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 instruments listed in the legend are part of the Quintex® system for anterior cervical fusion. The instruments are used for fixating the Quintex® plates and screws. The surgeon uses the instruments to adapt the Quintex® implants to the individual patient and to position and insert them. 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. For indications, see Intended use. 2.1.3 Contraindications No known contraindications.

2.2

Safety information

2.2.1

Clinical user

General safety information To prevent damage caused by improper setup or operation, and to not compromise the manufacturer warranty and liability: ► Use the product only according to these instructions for use. ► Follow the safety and maintenance instructions. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge and experience. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to use, check that the product is in good working order. ► Keep the instructions for use accessible for the user.

Note The user is obligated to report all severe events in connection with the product to the manufacturer and the responsible authorities of the state in which the user is located. Notes on surgical procedures It is the user's responsibility to ensure that the surgical procedure is performed correctly. Appropriate clinical training as well as a theoretical and practical proficiency of all the required operating techniques, including the use of this product, are prerequisites for the successful use of this product. The user is required to obtain information from the manufacturer if there is an unclear preoperative situation regarding the use of the product. 2.2.2

Product

Product-specific safety information The surgeon must have extensive and detailed knowledge of the stabilization techniques for the cervical spine and its biomechanical properties. The surgeon must also be familiar with the theory and practice of the relevant surgical techniques for the Quintex® system. ► Observe the instructions for use for Quintex® plates and screws (TA013366) and the corresponding operating manual (brochure no. O91702). ► SC431R/SC428R: Only use the product under X-ray vision. 2.2.3

Sterility

Art. no.

Designation

FJ833RS

Temporary fixation pin

The product is gamma-sterilized and supplied in sterile packaging. The product must not be reused. ► Observe the additional handling instructions. ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Do not use the product after its use-by date. ► See TA009932 "ABC temporary fixation pins" for further information.

2.3

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. 2.3.1 Determining the Quintex® plate length ► To determine the correct plate length, use caliper B or another appropriate means of measuring device. ► Use the scale to read the distance between the two ends. The drag indicator stays in its position and indicates the measured plate length, even if the arms of the caliper are closed again. Note The drag indicator must be returned to its initial position before each new measurement.

3

en 2.3.2 Bending the Quintex® plate The Aesculap Quintex® plates are supplied as pre-lordosed implants. They can be bent by means of the plate bender. The bending zone is the area between the pairs of holes within the bone graft window (window in the plate).

► To decrease the lordosis, place bending wedge 2 over the bending zone,

see Fig. 2.

2

1

Note In order to prevent excessive or insufficient lordosis, the long Quintex® plates should be bent in steps (one bending zone after another).

2

1

A

A

CAUTION Damage to the Quintex® implant due to excessive material stress! ► Quintex® plates should always be bent in one direction only. ► Quintex® plates should never be bent back. ► Always use the plate bender A to bend a Quintex® plate 1. ► Quintex® plate 1 should only be bent longitudinally and within the

bending zone. ► Avoid small bending radii, bending back, notching, and scratching of the Quintex® plate 1. ► Do not bend in the area of the pairs of holes. ► To increase the lordosis, place Quintex® plate 1 with the bending zone

positioned centrally between the two upper rolls of the plate bender A, see Fig. 1.

1

1

A

A

Fig. 3 Note The area on the instrument on which the lordosis of the plate can be reduced is labeled "STRAIGHTEN PLATE HERE". 2.3.3 Positioning and temporary fixation of the Quintex® plate To facilitate intraoperative handling, the Quintex® plate is first temporarily fixated on the vertebral body. This prevents any slipping of the Quintex® plate during the drilling procedure, and it allows for easier positioning of the screw holes and insertion of the Quintex® screws. For the positioning and temporary fixation of the Quintex® plate, the plate holding forceps O and instrument for fixation pins D are used. ► Check to make certain that the Quintex® plate is of the correct length. ► Use the plate holder forceps O to grasp the Quintex® plate 1 by the

outer edge, see Fig. 4. ► Compress the handles of the plate holding forceps to activate the lock. The plate holding forceps O now holds the Quintex® plate 1 without further pressure required on the handles. ► Quintex® plate 1 is then positioned on the spine, at the required height.

Fig. 1

O

1

1

1

2

Fig. 2

1

Fig. 4 ► As soon as the Quintex® plate 1 is correctly positioned, fix the plate

with fixation pins and further press the handles of the plate holding forceps O to release the lock. Note At least two fixation pins must be inserted for a secure fixation of the Quintex® plate. Use the instrument for fixation pins D for inserting the pins!

4

en ► Insert the fixation pin C into the instrument for fixation pins D. To do

this, pull back the outer sleeve 10 of the instrument for fixation pins D, see Fig. 5. ► To secure the fixation pin C, release outer sleeve 10 of the instrument for fixation pins D. The outer sleeve is then pushed forward by a spring mechanism.

C

D

10

D

10

2.3.4 Preparing the holes for the Quintex® screws The holes for the self-drilling and self-tapping Quintex® screws are prepared using the self-centering cortical center punch I. Alternatively, the outer sleeve of the cortical center punch I can also be removed and the cortical center punch I can be used in combination with a drill guide for preparing the holes. This opens up the cortical bone layer of the vertebral body and the screw can be screwed in without drilling. Or, the screw hole can be pre-drilled with drill K. To do this, position the drill K with the drill guide and use it manually with drill handle J, Q or mechanically with a motor system with Aesculap intra-handpiece (e.g. GD450R/GD456R). WARNING Risk of tissue trauma and incorrect pilot hole if the cortical center punch (without outer sleeve) or drill is inserted! ► Use the cortical center punch (without outer sleeve) and drill only in combination with single or double drill guides.

Fig. 5 ► Insert the fixation pin C through the fixation pin hole in the Quintex®

plate 1 into the vertebral body by applying a gentle hammer blow on the instrument for fixation pins D, see Fig. 6.

WARNING Incorrect pilot hole if the self-centering outer sleeve of the cortical center punch or a drill guide is not used! ► Always use the self-centering outer sleeve of the cortical center punch if the cortical center punch is used without a drill guide.

1 C

D

Fig. 6 ► To release the fixation pin C from the instrument for fixation pins D,

pull back outer sleeve 10 fully and remove instrument for fixation pins D from the fixation pin C, see Fig. 7.

1

C 10 D

Fig. 7

WARNING Incorrect pilot hole if drilling is carried out without a drill guide! ► Use the drill only in combination with the single or double drill guides.

Defining the center punch point/screw hole The following drill guides can be used: ■ Adjustable single drill guide E ■ Adjustable double drill guide F ■ Single drill guide, fixed (14 mm) G ■ Double drill guide, fixed (14 mm) H The screw insertion angle can be adjusted in a cranial-caudal direction. The screw insertion angle can also be adjusted in a medial-lateral direction when using a single drill guide or cortical center punch I. The guide sleeves 3 for drill guides E and F are interchangeable. Single drill guide E and double drill guide F are depth-adjustable. Fixed single drill guide G and fixed double drill guide H are designed for a center punch/drill depth of 14 mm (not depth-adjustable). Note The fixed single drill guide G and the fixed double drill guide H are labeled “14 mm” on the sleeve for easier identification. WARNING Risk of spinal cord trauma if the drill depth of the drill guide is incorrectly set! ► Insert the cortical center punch or drill in the drill guide and check the drill depth setting with a caliper or ruler. WARNING Risk of injury to the spinal cord of the patient if the self-centering cortical center punch is not used or is used incorrectly! ► Always use the self-centering cortical center punch with outer sleeve to determine the correct position for piercing the cortical bone.

5

en WARNING Damage to the Quintex® plate/screw and cortical center punch through the use of excessive force and torque when center punching or screwing in the Quintex® screw! ► Do not use the cortical center punch to prepare screw holes in hard bone, instead use a drill and tap. CAUTION Incorrect drill depth and damage through the use of a re-sharpened or shortened cortical center punch or drill! ► Do not re-sharpen the cortical center punch (without outer sleeve) and drill. ► Replace blunt cortical center punches and drills with new ones.

a

► Insert the cortical center punch (without outer sleeve) I or drill K into

the drill guide and check depth with caliper (e.g. 14 mm). ► To adjust the required drill depth with the depth-adjustable drill guides E and F (10 mm to 28 mm), turn guide sleeve 3 of the drill guide in direction + or –. Note The thread in the drill guide is a left-hand thread. Every half turn (= depth adjustment by 0.5 mm) you will hear and feel the guide sleeve clicking into position.

F K

3

3

K

b Fig. 8

3

3

Legend a Self-centering cortical center punch I complete b Self-centering cortical center punch I, without outer sleeve 11

3

K Fig. 9 ► Insert cortical center punch (without outer sleeve) I and drill K with

drill guides E, F, G or H only.

Fig. 10

Note The maximum penetration depth of the cortical center punch I with mounted outer sleeve is 6 mm.

K

J

Note The maximum penetration depth of the cortical center punch I through the drill guide is 6 mm to the shoulder between distal tip with trochar and the shaft. This shoulder will act as a stop on the cortical bone.

E

CAUTION Incorrect positioning of the center punch point or center punching too deep! ► Use the cortical center punch without outer sleeve only in combination with a drill guide. ► Do not center punch too deep.

I F

Fig. 11

6

en Assembling the drill and handle (optional) The drill and handle only need assembling if manual drilling is to be carried out. ► Use drill handle J or Q for manual drilling. ► Use the drill handle J or Q with the drill K only. ► Insert the drill K into drill handle J or Q: – Pull back locking sleeve 4 against the spring pressure, in the direction indicated by the arrow, and hold it there, see Fig. 12. – Slide the drill K into the adapter of the drill handle J or Q as far as it will go, see Fig. 13. – Slightly turn drill K while simultaneously releasing locking sleeve 4. The drill engages audibly.

4 J

K

a

b

A

a

b

B

a

b

C

Fig. 15 Legend A All holes of the hybrid plate B Distal slots of the dynamic plate C Middle slots of the dynamic plate a Correctly positioned Quintex® screw b Incorrectly positioned Quintex® screw 2.3.5 Tapping (optional) Quintex® screws are self-tapping screws. However, the screw holes can also be prepared with the tap L.

Fig. 12

L 4 K

click

3 J

Fig. 13 Correct positioning of center punch point/drill hole ► To position the center punch/drill hole correctly, insert the working end

of the drill guide 5 or working end of the self-centering cortical center punch I fully into the hole or slot of the Quintex® plate 1. ► To implant the screw correctly, position the center punch/drill hole in the center of the hole or centered in the slot along the long axis of the Quintex® plate 1, see Fig. 14. ► Open the cortical bone layer with the cortical bone punch I. - or ► Drill down to the set depth, using drill K. The depth stop stops the drill on the guide sleeve 3.

Fig. 16 ► Use tap L with the drill guide. ► Insert tap L into the drill guide and check the drill depth with a caliper

(e.g. 14 mm). ► To adjust the required tapping depth with the depth-adjustable drill

guides E and F (10 mm to 28 mm), turn guide sleeve 3 of the drill guide in direction “+” or “–”. Note The thread in the drill guide is a left-hand thread. Every half turn (= depth adjustment by 0.5 mm) you will hear and feel the guide sleeve clicking into position. ► Apply the working end of the tap through the drill guide into the pilot

E/F/G/H

hole. ► Turn the tap L clockwise in slowly and steadily as far as it will go. ► To remove the tap, turn it counterclockwise until it comes out of the pilot hole.

5

Fig. 14

7

en 2.3.6

► Screw the Quintex® screw into the hole or slot of the Quintex® plate 1

Inserting the screws

CAUTION Damage to the Quintex® plate and/or Quintex® screw when screwing in the plate if the screwdriver is applied incorrectly! ► Insert the working end of the screwdriver fully into the hexalobe (receptive part) of the screw. ► When screwing in the screw, maintain a mild axial pressure on the screw. CAUTION Damage to the locking ring or locking mechanism of the Quintex® screw, or destruction of the working end of the screwdriver if the screwdriver is applied at a slant or tilted! ► Always align the screwdriver with the axis of the screw. CAUTION Damage to the Quintex® screw or insufficient locking of the Quintex® screw if it is not correctly engaged in the hole or slot of the Quintex® plate! ► Ensure that the Quintex® screw correctly engages in the hole or slot of the Quintex® plate. ► Quintex® screw must not be screwed in too deep.

by applying mild pressure with screwdriver M, while rotating clockwise, until the screw head 7 fully engages in the hole or slot. ► Remove screwdriver M from the screw head 7. After removing the screwdriver M, the locking ring 8 must be flush with the screw head 7. ► Make certain that the Quintex® screw is securely locked in the Quintex® plate 1. The screw is securely locked when at least 3 of the 5 petals of the screw head are positioned in the hole/slotted hole of the Quintex® plate under the plate surface and both sides of the screw head are positioned in the hole or lotted hole underneath the plate surface from a lateral perspective.

M M

6

8 7

7 8

6

Note Screwdriver M is a self-holding screwdriver. A screw holding sleeve is not required. ► Insert the working end 6 of the screwdriver M fully into the screw

head 7. ► Make certain that the screwdriver holds the screw. 7

6

a

b

Fig. 18 M

Legend a Screw in plate hole or slot of the Quintex® plate, the screw unlocks automatically when it passes through the hole or slot and it locks as soon as it is fully inserted. b Screw correctly inserted and locked, top of the locking ring 8 sits flush with the screw head 7 ► Check the Quintex® screw is correctly seated in the hole or slot of the

M

Fig. 17

Quintex® plate: – If the Quintex® screw has not been fully screwed into the plate hole or slot, screw the screw in deeper by 1/4 to 1/2 turns clockwise. – If the Quintex® screw has been screwed in too deep, turn the screw by 1/4 to 1/2 turns counterclockwise.

a

b

c

Fig. 19 Legend a Screw not screwed into the hole or slot of the Quintex® plate fully. b Screw screwed into the hole or slot of the Quintex® plate too deep. c Correctly inserted screw 8

en 2.3.7 Removing fixation pins The instrument for fixation pins D is used to remove temporary fixation pins C. ► Attach the instrument for fixation pins D onto the fixation pin C. – To do this, pull back the outer sleeve 10 of the instrument for fixation pins D. – To secure the fixation pin C release outer sleeve 10 of the instrument for fixation pins D. The outer sleeve 10 is then pushed forward by a spring mechanism. ► Pull the fixation pin C out of the vertebral body. ► To release the fixation pin C from the instrument for fixation pins D: Pull back outer sleeve 10 fully and take out fixation pin C from instrument for fixation pins D.

► Quintex® screw is removed from the hole or slot of the Quintex® plate

by pulling and turning the instrument counterclockwise at the same time. ► If you encounter difficulties removing the Quintex® screw from the screw extraction instrument, use holding forceps P as a counter torque.

N

N N

9

7

7

7

1 9

2.3.8 Removing Quintex® implants Note Quintex® implants must only be removed with Quintex® instruments.

9

► To remove an implanted Quintex® screw, insert the tip of the screw

driver M fully into the screw head 7. ► When unscrewing the Quintex® screw with the screwdriver M main-

tain a mild axial pressure on the screw. ► Turn the screwdriver M counterclockwise to release the Quintex® screw. CAUTION Damage to the screw extraction instrument and Quintex® screw through improper use! The screw extraction instrument is only to be used to remove already free spinning Quintex® screws of which the screw heads do not automatically snap out of the screw hole or slot of the Quintex® plate. ► Never use the screw extraction instrument to insert Quintex® screws.

a

b

c

Fig. 20 Legend a Screw extraction instrument N before insertion in screw head 7 b Screw extraction instrument N inserted as far as it will go in the screw head 7, however not yet screwed in c Screw extraction instrument N fully screwed into the screw head 7 counterclockwise

CAUTION Damage to the screw after removing the free turning Quintex® screw! The screw extraction instrument damages the screw locking ring! ► No not reuse the screw after using the screw extraction instrument. ► Use a new screw. Note The thread on the tip of the screw extraction instrument is a left-hand thread. ► If the screw head 7 of the free turning Quintex® screw does not auto-

matically snap out of the hole or slot in the Quintex® plate 1 use screw extraction instrument N instead of screwdriver M. ► Insert the screw extraction instrument N as far as possible into the screw head 7. ► Turn the left-hand thread on the tip of the screw extraction instrument 9 counterclockwise into the screw head 7 as far as possible.

9

en 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".

10

3.3

Single-use products

Art. no.

Designation

FJ833RS

Fixation pin

► Do not reuse the product. The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

3.4

Reusable products

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.5

Preparations at the place of use

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

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

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

disinfection within 6 hours.

3.6

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly. ► Open up product with hinges.

en 3.7

Disassembly

3.7.3

3.7.1 Single drill guide SC423R and double drill guide SC424R Note The thread in the single drill guide SC423R and the double drill guide SC424R are left-hand threads. ► Remove guide sleeve 3 by turning it clockwise.

Self-centering cortical center punch SC428R

► Turn threaded cap counterclockwise to remove the outer sleeve 11

form the threaded cap. ► Remove outer sleeve 11 from the shaft of the self-centering cortical center punch I, see Fig. 23.

a

You will hear and feel the guide sleeve clicking into position every half turn.

b

3

11

I

Fig. 23

E

Legend a Cortical center punch I assembled b Removing the outer sleeve 11 from the cortical center punch I

E

3.7.4

Caliper SC421R

► Turn the knurled screw 12 of the caliper B counterclockwise until it is

fully disengaged, see Fig. 24.

3

B F

F

Fig. 21 3.7.2

Instrument for fixation pins SC422R

12

► Pull back sleeve 10 in the direction of the handle.

Fig. 24

► Turn sleeve 10 a quarter turn clockwise. ► Remove sleeve 10 from the instrument for fixation pins D.

3.8

Cleaning/Disinfection

3.8.1

a 10

D

b D Fig. 22 Legend a Instrument for fixation pins D assembled b Removing the sleeve 10 from the instrument for fixation pins D

Product-specific safety information on the reprocessing method Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastic material and stainless 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. ► Manually pre-clean the product (using a brush) if bone or tissue resi-

dues or residues of additives (e.g. flasking plaster) are present.

11

en 3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush: e.g. TA011327 for SC422R and SC428R,

Chapter Manual cleaning/disinfection and subsection:

■ SC410R ■ SC420R-SC426R ■ SC428R ■ SC430R-SC434R ■ FW076R

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

Manual cleaning with ultrasound and immersion disinfection

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

■ SC429R ■ SC436R

FO764200 for SC429R

■ Chapter Manual cleaning with immersion disinfection

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

■ Drying phase: Use a lint-free cloth or medical compressed air Chapter Manual cleaning/disinfection and subsection:

■ Chapter Manual cleaning with ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfection

■ Place the product on a tray that is suitable for cleaning (avoid

■ SC410R ■ SC420R-SC421R ■ SC430R–SC434R ■ FW076R

■ Connect components with lumens and channels directly to the

rinsing blind spots). rinsing port of the injector carriage.

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open.

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

■ SC422R-SC426R ■ SC428R

■ Suitable cleaning brush: e.g. TA011327 for SC422R and SC428R ■ 20 ml disposable syringe ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

■ Connect components with lumens and channels directly to the

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

rinsing port of the injector carriage.

■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ SC429R ■ SC436R

■ Suitable cleaning brush: e.g. FO764200 for SC429R and SC436R ■ 20 ml disposable syringe ■ Place the product on a tray that is suitable for cleaning (avoid rinsing blind spots).

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

■ Keep working ends open for cleaning. ■ Place the product on the tray with all product links and joints open.

12

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

■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and 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.

13

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.

14

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.

15

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.

16

en 3.11.2 Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible surfaces are immersed and acoustic shadows are avoided. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

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

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

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

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

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

ing.

17

en 3.12 Inspection ► Allow the product to cool down to room temperature. ► Dry the product if it is wet or damp.

3.12.1 Visual inspection ► Ensure that all soiling has been removed. In particular, pay attention to

mating surfaces, hinges, shafts, recessed areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the product for damage to the spiral element. ► Check the cutting edges for continuity, sharpness, nicks and other damage. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical service. 3.12.2 Functional test CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges,

locks/latches, sliding parts etc.). ► Check for compatibility with associated products. ► Immediately put aside inoperative products and send them to Aesculap Technical Service, see Technical service.

3.13 Assembly 3.13.1 Single drill guide SC423R and double drill guide SC424R Note The thread in the single drill guide SC423R and the double drill guide SC424R are left-hand threads. ► Attach guide sleeve 3 by turning it counterclockwise, see Fig. 20.

You will hear and feel the guide sleeve clicking into position every half turn.

3.13.2 Instrument for fixation pins SC422R ► Slide sleeve 10 over the shaft of the instrument for fixation pins D so that the milled slot in sleeve 10 is guided over the pin on the instrument shaft, see Fig. 21. ► Turn sleeve 10 a quarter turn counterclockwise (still guiding the slot over the pin). The spring pressure pushes the sleeve 10 forward automatically, see Fig. 21. 3.13.3 Self-centering cortical center punch SC428R ► Slide outer sleeve 11 over the shaft of the self-centering cortical center

punch I, see Fig. 23. ► To secure the outer sleeve 11 turn the threaded cap on the sleeve

clockwise. 3.13.4 Caliper SC421R ► Insert knurled screw 12 in the threaded hole and turn it clockwise until tight and there is sufficient resistance when the arms are opened, see Fig. 24.

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

than in the first notch. ► Place the product in its holder or on a suitable tray. Ensure that sharp

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

Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against con-

tamination of the product during storage.

3.15 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. Note To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further than on the first ratchet tooth. ► Check to ensure that the sterilizing agent will come into contact with

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

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

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

18