ABC system for anterior cervical fusion – Instruments for self-lockingscrews –

A

D

B

E

C

F

G

H

I

J

K

L

M

N

O

en

Aesculap® ABC ABC system for anterior cervical fusion – Instruments for selflocking screws – Legend

1.2

A Plate bender FJ826R B Temporary fixation pin FJ833RS C Plate holding forceps FJ890R D Single drill guide FJ822R E Double drill guide FJ823R F Bone awl to open up cortical bone FJ913R G Drill FJ840R H Drill handle FJ839R I Tapper FJ825R J Screw holding sleeve FJ821R K Screwdriver for self-locking screws FJ910R L Self-locking assistance instrument FJ911R M Screw-out sleeve for free-turning screws FJ912R N Double drill guide FJ834R O Pin insertion and extraction instrument FJ835R

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:

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 ABC system for anterior cervical fusion - Instruments for self-locking screws. 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 material compatibility and lifetime see B. Braun eIFU at eifu.bbraun.com

Safety messages

DANGER Indicates a possible threat of danger. If not avoided, death or serious injury may result. WARNING Indicates a possible threat of danger. If not avoided, minor or moderate injury may result. CAUTION Indicates a possible threat of material damage. If not avoided, the product may be damaged.

2.

Clinical use

2.1

Areas of use and limitations of use

2.1.1

Intended use

The 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

en 2.2

Safety information

2.2.1 Clinical user

2.2.2

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.

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. 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 of ABC plates and screws (TA011700) and the operating manual (brochure no. O17702 and no. O29602). ► 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).

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.

2.2.3

Product

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization. Single-use products Art. no.

Designation

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.

3

en 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 Adapting the ABC plates Bending 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. 1 ► To reduce the lordosis, position bending wedge 2

over the bending zone, see Fig. 2.

2 1

A

1

2 A

► Always use the plate bender A to bend the ABC

plate 1. ► Bend the ABC plate 1 longitudinally and within the

bending zone only. ► Avoid small bending radii, bending back and notch-

ing or scratching of the ABC plate 1. ► To increase the lordosis, insert the ABC plate 1 with

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

Fig. 2

2.3.2

Positioning and temporary fixation of an 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.

4

en The ABC plate can be positioned and temporarily fixated as follows: Positioning with plate holding forceps FJ890R and fixation with pin insertion and extraction instrument FJ835R. ► Please follow the instructions for use of 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. Application is described below. 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, see Fig. 3.

Note At least two fixation pins must be inserted for secure fixation of the ABC plate. Use the pin insertion and extraction instrument O to insert the pins. ► Insert the fixation pin B into the pin insertion and

extraction instrument O. ► To secure the fixation pin B, slide forward and twist

the outer sleeve of the pin insertion and extraction instrument O. ► Insert fixation pin B into the ABC plate 1 by lightly tapping with a hammer on the pin insertion and extraction instrument O, see Fig. 4.

B

O

1

Fig. 4

C

► To remove the pin insertion and extraction instru-

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

1 O 1

B Fig. 5 Fig. 3

5

en 2.3.3 Preparing the holes for the ABC screws The holes for self-tapping ABC screws are center punched using the cortical bone awl F and a drill guide: The cortical layer of the vertebral body is penetrated in this process so that the screw can be driven in without having to drill. Alternatively, the screw hole can be pre-drilled with drill G. The drill is applied with a drill guide and can be driven manually with drill handle H or with a motor system and Aesculap Intra handpiece (e.g. GD450R/GD456R). WARNING Incorrect drilling hole caused by drilling without a drill guide! Risk of tissue damage during introduction of the bone awl to open up the cortical bone, or of the drill! ► Always use the single or double drill guide when applying the bone awl. ► Always use the single or double drill guide when applying the drill. Calibrating the center punch point/screw hole The following drill guides can be used: ■ Single drill guide D FJ822R ■ Double drill guide E FJ823R ■ Double drill guide N FJ834R The screw insertion angle can be varied by +/–35° in caudocranial direction at foot plate 10, see Fig. 11. With the single drill 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 N features a fixed setting for a center punching/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 bone awl or drill into the drill guide and check the set center punching/cutting depth with a caliper (e.g. AA845R). DANGER Damage to the ABC plate/screw and bone awl through the use of excessive force and torque when center punching or screwing in the ABC screw! ► For hard bone, use a drill and tapper instead of the bone awl. CAUTION Incorrect drilling depth and damage caused by sharpened or shortened bone awl or drill! ► Do not sharpen the bone awl or drill. ► Replace blunt bone awls or drills with new ones. ► Use cortical bone awl F and drill G only with drill

guides D, E or N.

F

Fig. 6

G

5 4

6

Fig. 7 Note The maximum center punching depth with cortical bone awl F is 14 mm.

6

en ► Insert the cortical bone awl F or the drill G into the

drill guide and check with the caliper (e.g. 14 mm). ► To set the required cutting depth for the depthadjustable drill guides D and E (10 mm to 28 mm), turn the guide sleeve 3 of the drill guide in the + or – direction. 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.

3

E

F/G

F/G 3

Assembling the drill and handle (optional) The drill and handle only need assembling if manual drilling is to be carried out. ► Observe the instructions for use of the drill G (TA009931). ► Use the drill handle H for manual drilling. ► Use the drill handle H with the drill G only. ► Insert the drill G into the drill handle H: – Pull back locking sleeve 7 against the spring pressure, in the direction indicated by the arrow, and hold it there. – Push the drill G into the adapter of the drill handle H as far as it will go, see Fig. 9. – Turn the drill G slightly while simultaneously letting go of the locking sleeve 7, see Fig. 10. The drill engages audibly.

3

7

3

G 14 mm

1

H 8 Fig. 9

Fig. 8

7 G H Fig. 10

7

en Correct positioning of center punch point/drill hole ► To position the center punch/screw hole correctly, fully insert tip 9 of the drill guide into the hole of ABC plate 1, see Fig. 11. Apply the center punch/screw hole centrally in the hole of the ABC plate so that the screw can be inserted correctly.

E

10

► Open the cortical layer with cortical bone awl F.

–or– ► Drill down to the set depth, using drill G.

The stop unit stops the drill on the guide sleeve. ► For ensuring the dynamics of the ABC system:

– 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.

9 1

1 Fig. 11

1

b

a Fig. 13

2.3.4

Fig. 12 Legend a Incorrectly positioned ABC screw b Correctly positioned ABC screw

8

Tapping (optional)

ABC screws are self-tapping screws. However, a thread can be prepared for them using the tapper I, if required. ► To adjust the cutting depth at tapper I, see Fig. 14: – Pull back guide sleeve 11 of the tapper I 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).

en ► Never use the screwdriver K without the screw-

13 12

holding sleeve J, see Fig. 15. the screw-holding sleeve J onto the screwdriver K. ► Fully insert the tip 14 of the screwdriver K into the screw head 15. ► Slide the screw holding sleeve J over the screw head 15. The locking pin is pushed down and unlocks the ABC screw. ► Slide

11

12 13

I

Fig. 14 ► Put the tip of the tapper I onto the drilling hole pre-

K

pared beforehand.

J

► Slowly drive in tapper I, in even turns, as far as it

J

will go.

2.3.5 Inserting the screws CAUTION Damage to the ABC plate or ABC screw in the course of driving the screw through the ABC plate, caused by incorrectly applied screwdriver! ► Fully insert the tip of the screwdriver into the hexagon socket of the screw locking pin. ► Always completely push down the locking pin when driving in the screw. CAUTION Damage to the locking pin or locking mechanism of the ABC screw, or destruction of the screwdriver tip caused by slanting application or tilting of the screwdriver! ► Always align the screwdriver with the axis of the screw. CAUTION Damage to the ABC plate/screw or incorrect locking of the ABC screw through incomplete engagement in the hole of the ABC plate or excessive tightening of the ABC screw! ► Ensure that the ABC screw fully engages in the hole of the ABC plate. ► Ensure that the ABC screw is not screwed in too far.

14

15

K

J Fig. 15

► Screw in ABC screw into the hole of the ABC

plate 1 by applying mild pressure with the screwdriver K, until the screw head 15 fully engages in the screw hole, see Fig. 16. ► Detach the screwdriver K from the screw head 15. The silver-colored locking pin 16 moves up while the screwdriver is detached, and locks the ABC screw. The locking ends up flush with the screw head or slightly protruding from it.

1 J 16 15

K

14

Fig. 16 If the locking pin does not come flush with the screw head: WARNING Failure to achieve the required quality of stabilization due to incorrect locking of the ABC screw! ► If the locking pin does not move up as described above, use the self-locking assistance instrument to pull the locking pin up fully and lock the ABC screw.

9

en ► Check that the ABC screw is correctly installed in

the plate hole, see Fig. 17: – If the ABC screw has not been fully screwed into the plate hole, screw it in deeper by 1/4-1/2 turns. – If the ABC screw has been screwed in too deeply, loosen it by 1/4-1/2 turns.

16

1

L

15

Fig. 19

2.3.6

K

Removing the fixation pins

► Use the pin insertion and extraction instrument O

14

14

to remove the temporary fixation pins B.

2.3.7

Removing ABC implants

Always use ABC instruments to remove ABC implants.

15 16 Fig. 17 Insufficiently screwed-in screw (left), screw screwed in too deeply (center), correctly locked screw (right) If the pin has not yet moved up: the special self-locking assistance instrument L to lock the screw, see Fig. 18.

► Use

L

CAUTION Damage to the screw-out sleeve and the ABC screw caused by incorrect application! ► Never use the screw-out sleeve to screw in or screw out fixated ABC screws. ► The screw-out sleeve is only intended for removing free-turning ABC screws whose heads fail to snap out of the ABC plate hole. ► Fully insert the tip 14 of the screwdriver K into the

screw head 15. At the same time, unlock the screw by applying mild pressure to push the locking pin into the screw. ► Unscrew the ABC screw using the screwdriver K.

J

Fig. 18

J

► Hold self-locking assistance instrument L at its

shaft and turn the tip clockwise into locking pin 16 of the ABC screw, as far as it will go (approx. 3 to 4 turns), see Fig. 19. ► To lock screw 15, hold the self-locking assistance

instrument L at its shaft and carefully pull up locking pin 16 until the locking pin sits flush with the screw head or slightly protrudes from it. The screw is locked now. ► Hold self-locking assistance instrument L at its shaft, turn counterclockwise and remove from the locking pin 16.

15

15

1 Fig. 20

10

K 14

K 14

en ► If the screw head 15 of a free-turning screw does

not snap out of the hole of the ABC plate 1, use special screw-out sleeve M for free-turning screws: – Remove the normal screw holding sleeve J from the screwdriver K. – Slide the screw-out sleeve M for free-turning screws onto the screwdriver K. – Fully insert the tip of the screwdriver K into the screw head 15. – Align the screw-out sleeve M so that the jaw piece can sink in next to the screw head into slotted hole of the ABC plate. When doing this, ensure that the gap between the screw and the plate is sufficiently wide for the jaw piece to engage around the screw head. – Slide outer sleeve 20 forward as far as it will go, taking care hat the sleeve does not completely slip off from the screwdriver. – Remove the ABC screw by simultaneously pulling and turning the screwdriver handle counterclockwise.

K M

15

1 Fig. 21

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.

M 20

Note If there is no final sterilization, then a virucidal disinfectant must be used.

15

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.

20

15

3.

1

11

en 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 pre-cleaning 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 "AKI-Brochures", "Red brochure".

12

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

► Do not disassemble fixation screws which perma-

nently connect the various components. ► Disassemble the product prior to cleaning, see Dis-

assembly/Assembly.

en 3.7

Disassembly/Assembly

3.7.1 Single drill guide FJ822R and double drill guide FJ823R

Assembly ► Push the pivot sleeve 17 onto the drill handle H

against the direction of the arrow.

3.7.3

Tapper FJ825R

I 3

3

11

Fig. 24 Disassembly ► Loosen guide sleeve 11 and remove it from tapper I in the direction of the arrow. Assembly ► Slide guide sleeve 11 over tapper I in the direction of the arrow and fasten by turning it clockwise.

3.7.4

Screw-out sleeve for free-turning screws FJ912R

Fig. 22

M

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.

20

19

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

19

3.7.2 Drill handle FJ839R 20

H

17 Fig. 25

Fig. 23 Disassembly ► Pull the pivot sleeve 17 from the drill handle H in the direction of the arrow.

Disassembly ► Pull the outer sleeve 20 of screw-out sleeve M in the direction of the arrow. ► Turn outer sleeve 20 in the direction of the arrow. ► Slide off outer sleeve 20 from inner sleeve 19.

13

en Assembly ► Slide outer sleeve 20 over the inner sleeve 19, so that the milled recess in the outer sleeve 20 is guided over the spigot on the inner sleeve 19. ► Twist outer sleeve 20 against the direction of the arrow, and slide it over the inner sleeve.

3.7.5 Pin insertion and extraction instrument FJ835R

18

O Fig. 26 Disassembling ► Pull the sleeve 18 in the direction of the arrow. ► Turn sleeve 18 in the direction indicated by the arrow. ► Pull off the sleeve 18 from the pin insertion and extraction instrument O. Assembly ► Slide the sleeve 18 over the shaft of the pin insertion and extraction instrument O so that the milled recess in sleeve 18 is guided over the spigot on the instrument. ► Turn sleeve 18 against the direction indicated by the arrow and push it onto the instrument.

14

3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method

Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for use e.g. on aluminum, plastic materials 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. ► 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 ► If the microsurgical 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 3.8.2 Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection ■ FJ821R

■ Use suitable cleaning brush, e.g.:

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

■ FJ822R ■ FJ823R ■ FJ825R ■ FJ826R ■ FJ834R ■ FJ835R ■ FJ839R ■ FJ890R ■ FJ910R ■ FJ911R ■ FJ812R ■ FJ913R Manual cleaning with ultrasound and immersion disinfection ■ FJ828R

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

■ Disposable syringe 20 ml ■ Keep working ends open for cleaning.

■ When cleaning instruments with movable hinges, ensure that these are in an open position and, if applicable, move the hinge while cleaning.

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

Chapter Manual cleaning/disin■ Use suitable cleaning brush fection and subsection: ■ Disposable syringe 20 ml ■ Chapter Manual cleaning ■ Keep working ends open for cleanwith ultrasound and immering.

■ When cleaning instruments with

sion disinfection

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

■ Drying phase: Use a lint-free cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection ■ FJ821R

■ Place the product on a tray that is

■ FJ826R ■ FJ840R ■ FJ890R ■ FJ910R ■ FJ911R ■ FJ913R

■ Connect components with lumens

suitable for cleaning (avoid rinsing blind spots). and channels directly to the rinsing port of the injector carriage.

Chapter Mechanical cleaning/disinfection and subsection: ■ 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.

15

en Validated procedure

Specific requirements

Reference

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection ■ FJ822R

■ Cleaning brush:

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection: ■ Chapter Manual pre-cleaning with a brush

■ FJ823R ■ FJ825R ■ FJ828R ■ FJ834R ■ FJ835R ■ FJ839R ■ FJ912R

– for FJ821R and FJ912R e.g. TA006874 – for FJ825R e.g. TA011944 – for FJ835R brush length 50 mm/∅: 3.8 mm, 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.

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.

16

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

en 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: FD–W:

Drinking water 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/disinfec-

tant 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 running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully.

Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces). ► Mobilize non-rigid components, such as set screws, joints, etc. during final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully. Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

17

en 3.9.2 Manual cleaning with ultrasound and immersion disinfection 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

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: FD–W:

Drinking water 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 running water. ► Mobilize non-rigid components, such as set screws,

joints, etc. during rinsing. ► Drain any remaining water fully.

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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 running 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.