ABC system for anterior cervical fusion - Instruments -

B

A

E

C

F

G

D

H

I

J

K

L

M

N

en

Aesculap® ABC ABC system for anterior cervical fusion - Instruments Legend

2.

Clinical use

A B C D E F G H I J K L M N

Plate bender FJ826R Temporary fixation pin FJ833RS Plate holding forceps FJ890R Single drill guide FJ822R Double drill guide FJ823R Drill FJ840R Drill handle FJ839R Tapper FJ825R Screw holding sleeve FJ821R Screwdriver FJ845R Locking instrument FJ828R Revision instrument FJ829R Double drill guide FJ834R Pin insertion and extraction instrument FJ835R

2.1

Areas of use and limitations of use

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 ABC system for anterior cervical fusion Instruments. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on mate-

rial compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2

2.1.1 Intended use The ABC system for anterior cervical fusion includes the instruments listed above. These instruments are used for fixating ABC plates and screws. They enable the surgeon to adapt ABC implants individually for each patient and to position and insert the implant. 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 Risk of injury caused by incorrect operation of the product! ► Attend appropriate product training before using the product. ► For information about product training, please contact your national B. Braun/Aesculap agency.

en The operating surgeon must be thoroughly conversant with stabilization techniques for, and the biomechanical properties of, the cervical spine. He must also be familiar with the theory and practice of operative techniques within the ABC system. ► Observe the instructions for use for ABC plates and screws (TA09693) and the operating manual (brochure no. O17702). ► Do not use the product if it is damaged or defective. Set aside the product if it is damaged. ► Replace any damaged components immediately with original spare parts. ► To prevent damage at the working end: carefully insert the product through the working channel (e.g. trocar).

► Always use the plate bender A to bend an ABC plate 1. ► Bend the ABC plate 1 longitudinally and within the bending zone only. ► Avoid small bending radii, bending back, notching or scratching the

ABC plate 1.

2.2.3 Sterility The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Single-use products

Fig. 1

Art. no.

Designation

► To strengthen lordosis: Place ABC plate 1 with the bending zone posi-

FJ833RS

Temporary fixation pins

The product has been gamma-sterilized and is supplied in sterile packaging. ► 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. ► Do not use products from open or damaged sterile packaging. ► Do not use the product after its use-by date.

2.3

tioned centrally between the two upper rolls of the plate bender A. ► To reduce lordosis: Position the bending wedge 2 above the bending

zone.

1

2 1

2

A A

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. 2.3.1 Adapting the ABC plates The ABC plates supplied by Aesculap are supplied as pre-lordosed implants. They can be bent by means of the plate bender. The bending zone is located between the pairs of holes in the plates. It has the shape of a waisted depression in the material. Note With long ABC plates, bending should be carried out in steps (bending zone by bending zone) in order to avoid excessive or insufficient lordosation. CAUTION Damage to the ABC implant through excessive strain on the material! ► Always bend the ABC plate in one direction only. ► Do not bend back the ABC plate.

Fig. 2 2.3.2 Positioning and temporary fixation of the ABC plate To facilitate the intraoperative handling, the ABC plate is temporarily fixated on the vertebrae. This prevents any slipping of the ABC plate during the drilling procedure, and it allows an easier positioning of the drill holes and insertion of the ABC screws. The plate is positioned with plate holding forceps FJ890R and fixated with pin insertion and extraction instrument FJ835R. ► Observe instructions for use for the fixation pin B (TA009932 and TA011911). ► Check to make certain that the ABC plate is of the correct length. ► Prior to positioning the ABC plate, verify that arrow UP points towards cranial.

3

en Positioning an ABC plate with the plate holding forceps and fixating it with the pin insertion and extraction instrument ► Use plate holding forceps C to grasp any two opposite plate holes of ABC plate 1. ► Compress the handles of the plate holding forceps to activate the lock. The plate holding forceps now holds the ABC plate without further pressure required. ► Position ABC plate 1 on the spine, at the required height. ► As soon as the ABC plate 1 is correctly positioned, further press the handles of plate holding forceps C to release the lock.

► To remove the pin insertion and extraction instrument, turn the ring

handle of the pin insertion and extraction instrument N and pull back as far as it will go, see Fig. 5.

1 N

B Fig. 5

C

1

Fig. 3 ► Insert fixation pin B in pin insertion and extraction instrument N, see

Fig. 4. ► To secure the fixation pin B, slide forward and twist the outer sleeve of

the pin insertion and extraction instrument N. ► Insert fixation pin B into the ABC plate 1 by lightly tapping with a

hammer on the pin insertion and extraction instrument N.

B

1

N

Note At least two fixation pins must be inserted for secure fixation of the ABC plate. Fixation pins are applied using the pin insertion and extraction instrument N, as described below. 2.3.3 Drilling the holes for the ABC screws For drilling the holes for the ABC screws, the drill F is used. The drill is applied with a drill guide and can be driven manually with drill handle G or with a motor system and Aesculap Intra handpiece (e.g. GD450R/GD456R). The following drill guides can be used: ■ Single drill guide D ■ Double drill guide E ■ Double drill guide M The screw insertion angle can be varied by +/–35° in caudocranial direction at foot plate 10, see Fig. 10. Additionally, with the single drilling guide, an angle adjustment of +/8° in mediolateral direction is also possible. The guide sleeves of the drill guides D and E are replaceable. The single drill guide D and the double drill guide E are depth-adjustable. The double drill guide M features a fixed setting for a cutting depth of 14 mm (not adjustable). DANGER Risk of drilling into the patient’s spinal cord as a result of the cutting depth set incorrectly on the drill guide! ► Insert the drill into the drill guide and check the set cutting depth with a calliper (e.g. AA845R). CAUTION Incorrect cutting depth and damage through repointed or shortened drills! ► Never repoint the drill. ► Any blunt drill must be replaced by a new one. CAUTION Incorrect drilling hole caused by drilling without a drill guide! ► Always use a drill guide when drilling the holes.

F

Fig. 4

5

4 Fig. 6 ► Use drill F only with drill guides D, E or M. ► Observe the instructions for use for drill F (TA009931).

4

6

en ► Insert the drill F into the drill guide and check with a calliper (e.g.

► To position the screw hole correctly, fully insert the tip 9 of the drill

25 mm), see Fig. 7. ► To set the required cutting depth for the depth-adjustable drill guides D and E (10 mm to 28 mm), turn the guide sleeve 3 of the drill guide in the + or – direction, see Fig. 7. Note that the thread of drill guide is of the left-handed type. Every half turn (= height adjustment by 0.5 mm) you will hear and feel the guide sleeve clicking into position.

guide into the hole of the ABC plate 1, see Fig. 10. Place the screw hole centrally in the hole of the ABC plate so that the screw can be inserted correctly. ► Drill to the preset cutting depth. The stop unit stops the drill on the guide sleeve.

Fig. 10 Fig. 7

1

► For manual drilling, use the drill handle G. ► The drill handle G can be used with the drill F only. ► Insert the drill F into the drill handle G:

– Pull back locking sleeve 7 against the spring pressure, in the direction indicated by the arrow, and hold it there, see Fig. 8. – Slide the drill F into the adapter of the drill handle G as far as it will go, see Fig. 8. – Turn the drill F slightly while simultaneously letting go of the locking sleeve 7, see Fig. 9. The drill engages audibly.

7

F G Fig. 11 A correctly positioned ABC screw (left), an incorrectly positioned ABC screw (right)

8

► For ensuring the dynamics of the ABC system:

Fig. 8

– Screw the ABC screws cranially into the holes at the cranial end of ABC plate 1 as deeply as possible. – Screw the ABC screws caudally into the holes at the caudal end of ABC plate 1 as deeply as possible. – Screw the ABC screws centrally into the holes at the centre of ABC plate 1.

7 F G

Fig. 9

5

en ► Never use the screwdriver J without the screw holding sleeve I. ► Slide the screw holding sleeve I onto the screwdriver J. ► Fully insert the tip 14 of the screwdriver J into the screw head 15.

The locking pin is pushed down and unlocks the ABC screw. ► Slide the screw holding sleeve I over the screw head 15.

15 14

Fig. 12

I

I

J

Fig. 14

2.3.4 Tapping the threads When using bicortical ABC screws, the thread must be precut with the tap H. Monocortical ABC screws are self-tapping. When using the latter, precutting of the thread is not necessary. ► Adjust the cutting depth at the tap H: – Pull back guide sleeve 11 of the tapper H against the spring pressure in the direction of the arrow, until the pin 12 comes out of the groove 13. – Turn guide sleeve 11 until the required cutting depth is reached. The cutting depth of the tapper has to be set in accordance with the cutting depth (or to the nearest shorter setting). ► Put the tip of the tap H onto the drilling hole prepared beforehand. ► Slowly turn in the tap H, with even movements, until it reaches the positive stop.

13

► Screw in ABC screw into the hole of the ABC plate 1 by applying mild

pressure with the screwdriver J, until the screw head 15 fully engages in the screw hole, see Fig. 15. ► Remove the screwdriver J from the screw head 15. If the screwdriver J cannot be removed: – If the ABC screw has not been fully screwed into the plate hole, screw in the ABC screw deeper by 1/4 to 1/2 turns. – If the ABC screw has been screwed in too deeply, loosen the ABC screw by 1/4 to 1/2 turns.

1

12

J 16

15

I

14

Fig. 15

11

12 13

H

Fig. 13 2.3.5

Inserting the screws

CAUTION Damage to the ABC screw through incorrect application of the screwdriver when screwing into the ABC plate. ► Fully insert the tip of the screwdriver into the screw head. CAUTION Damage to the ABC screwdriver and the ABC screw or breakage of the screwdriver tip, respectively, through angled insertion or tilting of the screwdriver! ► Always align the screwdriver with the axis of the screw. CAUTION Damage to the ABC screwdriver and the ABC screw or incorrect locking of the ABC screw through incomplete engagement in the hole of the ABC plate. ► Ensure that the ABC screw fully engages in the hole of the ABC plate.

6

Fig. 16 Screw fully screwed in (left), screw not fully screwed in (right)

en 2.3.6 Locking the ABC screw ABC screws are locked by means of the locking instrument K. The tip of the locking instruments has to be fully pushed out (the inner sleeve fully pushed forward) for application. ► Push forward the tip of the locking instrument K: – Hold the locking instrument K at the outer shaft 17, with one hand. – Push the handle 18 in the direction indicated by the arrow, see Fig. 17. You will hear and feel the tip of the locking instrument clicking into position.

19 17

2.3.7 Removing the fixation pins ► Use the pin insertion and extraction instrument N to remove the temporary fixation pins B. 2.3.8 Removing ABC implants Always use ABC instruments to remove ABC implants. CAUTION Damage to the revision instrument and the ABC screw through improper application! ► Never use the revision instrument to screw in or unscrew ABC screws. ► Only free-turning ABC screws, whose heads do not snap out of the hole of the ABC plate, must be unscrewed with the revision instrument. ► To unlock the ABC screw, push the locking pin 16 into the screw, using

the screwdriver J.

18

K

► Unscrew the ABC screw using the screwdriver J.

Fig. 17 ► Hold the locking instrument K at the handle 18 and turn the tip clock-

wise into the locking pin 16 of the ABC screw until it hits its positive stop (approx. 4–5 turns), see Fig. 18. Make sure that the locking instrument K is not held at the outer shaft 17. ► If the locking instrument K unlocks and the inner sleeve snaps back, repeat the step of pushing forward the tip of the locking instrument K.

19

K

18

15 16

1

Fig. 18 ► To lock the screw head 15, hold locking instrument K by the handle 18

and press the button 19, see Fig. 19. Make sure that the locking instrument K is not held at the outer shaft 17. ► Turn the tip of the locking instrument K anticlockwise, thereby removing it from the locking pin 16. The locking pin sits flush with the screw head; the screw is locked.

19

K

18

Fig. 20 ► If the screw head 15 of a free-turning screw does not snap out of the

hole of the ABC plate 1, use special revision instrument L. – Insert the radial pins 20 of the revision instrument L, as far as they will go, into the slots between the segments of the screw head 15. – Remove the ABC screw by simultaneously pulling and turning it anticlockwise.

19 16

1

K 15 16

L

15

L

L

18

20 15

15

15

1

Fig. 19

1

1

1

Fig. 21

7

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".

8

3.3

Single-use products

Art. no.

Designation

FJ833RS

Temporary fixation pins

► 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/Assembly.

3.7

Disassembly/Assembly

3.7.1

Single drill guide FJ822R and double drill guide FJ823R

3

3

Fig. 22 Disassembly ► Remove guide sleeve 3 by turning it clockwise. Be aware that it is a left-handed thread. You will hear and feel the guide sleeve clicking into position every half turn.

en Assembly ► Attach guide sleeve 3 by turning it anticlockwise. Be aware that it is a left-handed thread. 3.7.2

3.7.5

Pin insertion and extraction instrument FJ835R

22

Drill handle FJ839R

G

N

21 Fig. 26 Disassembly

► Pull the sleeve 22 in the direction indicated by the arrows. ► Turn sleeve 22 in the direction indicated by the arrow.

Fig. 23

► Pull off sleeve 22 from pin insertion and extraction instrument N.

Disassembling ► Pull the pivot sleeve 21 from the drill handle G in the direction indi-

cated by the arrows. Assembly ► Push the pivot sleeve 21 onto the drill handle G against the direction

indicated by the arrows. 3.7.3

so that the milled slot in sleeve 22 is guided over the spigot on the instrument. ► Turn sleeve 22 against the direction indicated by the arrow and push it onto the instrument.

3.8

Tapper FJ825R

H

Cleaning/Disinfection

3.8.1

11

Fig. 24 Disassembly ► Loosen the guide sleeve 11 and remove it from the tap H in the direc-

tion of the arrow. Assembly ► Push the guide sleeve 11 over the tap H in the direction of the arrow

and fasten it by turning it clockwise. 3.7.4

Assembling ► Slide sleeve 22 over the shaft of insertion and extraction instrument N

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 e.g. for plastic materials 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

Locking instrument FJ828R

19 17

K

18

Fig. 25 Disassembly ► Extract the outer shaft 17 from the locking instrument K in the direc-

tion indicated by the arrows. Assembly ► Slide the outer shaft 17 onto the locking instrument K against the

direction indicated by the arrows. ► Push the button 19 into the handle 18 until it clicks into the first

catch.

9

en 3.8.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Cleaning brush:

Chapter Manual cleaning/disinfection and subsection:

■ FJ821R ■ FJ822R ■ FJ823R ■ FJ825R ■ FJ826R ■ FJ829R ■ FJ834R ■ FJ835R ■ FJ839R ■ FJ845R ■ FJ890R

– for FJ821R e.g. TA006874 – for FJ835R brush length: 50 mm/∅: 3.8 e.g. TA011327

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

■ 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

Manual cleaning with ultrasound and immersion disinfection

■ Cleaning brush:

■ FJ828R

■ Chapter Manual cleaning with ultrasound and ■ Disposable syringe 20 ml immersion disinfection ■ Keep working ends open for cleaning. ■ When cleaning instruments with movable hinges, ensure that

– for FJ825R e.g. TA011944

Chapter Manual cleaning/disinfection and subsection:

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 Mechanical alkaline cleaning and thermal disinfection

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

■ FJ821R ■ FJ826R ■ FJ829R ■ FJ840R ■ FJ845R ■ FJ890R

■ Connect components with lumens and channels directly to

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

■ Cleaning brush:

■ FJ822R ■ FJ823R ■ FJ825R ■ FJ828R ■ FJ834R ■ FJ835R ■ FJ839R

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

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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

– for FJ825R e.g. TA011944 – for FJ821R e.g. TA006874 – for FJ835R brush length: 50 mm/∅: 3.8 e.g. TA011327

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

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

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

10

Chapter Mechanical cleaning/disinfection and subsection:

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

■ Chapter Manual pre-cleaning with a 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.

11

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.

12

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.

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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

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

syringes, see Validated cleaning and disinfection procedure.

cleaning.

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

► Thoroughly rinse through these components with the cleaning disin-

fectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

3.11.2 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. 14

en 3.12 Inspection

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

► Allow the product to cool down to room temperature.

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.

► 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 Disassembly/Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges,

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

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

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

protected, dry, dark and temperature-controlled room.

4.

Technical service

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

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

Technical Service, see Technical service.

3.13 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.

5.

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

3.14 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.

15