Flexible arm

FF161R/FF163R/FF165R/FF431R 1

a

2

a

3

FF270R 4

5

9

6

5 5 7 10

8

12

2.1 6

11

9

2.2

10 5

FF431R A

9

B 9

1 10 5

2.2

13

C

5

15

FF180R

9

D

10

5

8

F

E

FF161R/FF163R/FF165R 5

7

14 5

G 8

FF273R/FF274R 5

5

7

7

I

H 6

6

FF266R/FF267R/FF268R FF282R/FF283R/FF284R 18

8 20

J

19

16 17

21

5

K

en ®

Aesculap Flexible arm Legend 1 Clamping nut 2 Clamping element 2.1Clamping element for Gilsbach system 2.2Clamping element for wound retractor 3 Threaded bush 4 Bearing disc 5 Flexible clamping arm 6 Wing nut 7 Spatula holder FF273R/FF274R (accessory) 8 Fixation gear FF266R/FF267R/FF268R (accessory) 9 Clamping screw 10 Rotary ring 11 Tensioning wire 12 Connection rail for fixation gear FF266R/FF267R/FF268R or coupling head FF282R/FF283R/FF284R 13 Wound retractor 14 Hand rest FF153R 15 Tray for swabs FF180R (accessory) 16 Coupling head FF282R/FF283R/FF284R (accessory) 17 Fixation screw 18 Clamping lever 19 Support arm FF285R 20 Variable position clamp 21 Skull fixation clamp

2.3

Assembly

2.3.1

Clamping arm FF161R/FF163R/FF165R/FF431R

Assembling clamping arm FF161R/FF163R/FF165R/FF431R ► To ensure the flexible clamping arm 5 is securely tensioned: Turn the threaded bush 3 clockwise onto the flexible clamping arm 5 until it rests on the bearing disc 4. ► Turn the clamping nut 1 clockwise onto the clamping element 2 until the clamping nut sits loosely and can still be turned. ► Insert the flexible clamping arm 5 with threaded bush 3 into the hexagon of the clamping element 2. ► Turn the clamping nut 1 clockwise until the flexible clamping arm 5 is slightly tensioned. Attaching clamping arm FF431R to the wound retractor ► Attach the flexible clamping arm 5 to the wound retractor and tighten the wing screw of the clamping element 2.2. ► Check it is securely connected. Attaching clamping arm FF161R/FF163R/FF165R to hand rest FF153R ► Attach the flexible clamping arm 5 to the hand rest 14 and tighten the clamping screw of the clamping element 2.1. ► Check it is securely connected.

2.3.2

Clamping arm FF270R

Fastening the clamping arm to the fixation gear FF266R/FF267R/FF268R ► Push the flexible clamping arm 5 onto the fixation gear 8 in the direction of the arrow, see Fig. G. ► Check it is securely connected. Fastening the clamping arm to the coupling head FF282R/FF283R/FF284R ► Push the flexible clamping arm 5 onto the coupling head 16 and tighten the flap screws 17 of the coupling head, see Fig. J. ► Check it is securely connected.

2.3.3

Fixation gear FF266R/FF267R/FF268R

Fastening the fixation gear onto the rod/skull ► Carefully place the fixation gear 8 onto the rod or skull cap and carefully tighten the wing screw 21, see Fig. K. ► Check it is securely connected.

a Lubrication points

2.3.4

1.

Assembling the coupling head ► Gently screw the clamping screw 18 into the coupling head 16. ► Screw all distance rollers 20 and flap screws 17 into the coupling head.

About this document

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

1.1

Scope

These instructions for use apply to flexible arms and the belonging accessories. 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

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 Aesculap flexible arm is used for holding spatulas in neurosurgical procedures. The flexible arm can be positioned individually. The flexible arm can also be used as a holder for the tray for swabs.

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

Sterility

The product is delivered in an unsterile condition. ► Clean the new product after removing its transport packaging and prior to its initial sterilization.

Coupling head FF282R/FF283R/FF284R

Fastening the coupling head to the support arm ► Push the coupling head 16 onto the support arm 19 and tighten securely with the clamping screw 18, see Fig. J. ► Check it is securely connected.

2.3.5

Spatula holder FF273R/FF274R

Mounting the spatula holder on the clamping arm ► Place the spatula holder 7 onto the screw collet of the flexible clamping arm 5 and gently tighten with wing nut 6, see Fig. I. ► Insert the appropriate flat spatula/spatula with round shaft or tray for swabs 15 into the slightly open spatula holder 7 and fully tighten with the wing nut 6. ► Check it is securely connected.

2.4

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.

2.4.1

Clamping arm FF161R/FF163R/FF165R/FF431R

► To tension the flexible clamping arm 5 or increase the holding force, turn the clamping nut 1 clockwise. ► To slacken the clamping arm 5, turn the clamping nut 1 counterclockwise.

2.4.2

Clamping arm FF270R

Tensioning the clamping arm CAUTION Tensioning rope rupture due to excessive pre-tensioning of the rotary ring! ► Tighten the rotary ring only slightly. ► Turn the rotary ring 10 onto the clamping screw 9 in the direction of the arrow, see Fig. A.

The holding force in the flexible clamping arm 5 is increased. ► To lock clamping screw 9 turn clamping screw 9 clockwise, see Fig. B. ► If the clamping screw 9 does not lock, turn the rotary ring 10 onto the flexible clamping arm 5 in the direction

of the arrow, see Fig. C. The holding force in the flexible clamping arm 5 is reduced. Note To allow later smooth repositioning of the flexible clamping arm 5, the holding force should be adjusted to a setting only slightly stronger than the required force. Slackening the clamping arm ► Turn the clamping screw 9 counterclockwise, see Fig. D. ► Turn the rotary ring 10 onto the flexible clamping arm 5 in the direction of the arrow as far as it will go, see Fig. E.

2.5

Disassembly

2.5.1

Clamping arm FF161R/FF163R/FF165R/FF431R

Releasing the clamping arm FF431R from the wound retractor ► Loosen the wing screw of the clamping element 2.2 and remove the flexible clamping arm 5 from the wound retractor 13. Removing the clamping arm FF161R/FF163R/FF165R from the hand rest FF153R ► Loosen the clamping screw of the clamping element 2.1 and remove the flexible clamping arm 5 from the hand rest 14. Disassembling clamping arm FF161R/FF163R/FF165R/FF431R ► Turn the clamping nut 1 counterclockwise, until the flexible clamping arm 5 can be withdrawn from the clamping element 2. ► Continue to turn the clamping nut 1 counterclockwise and remove it from the clamping element 2. ► Turn the threaded sleeve 3 on the clamping arm 5 counterclockwise, until the threaded sleeve detaches from the clamping arm.

2.5.2

Clamping arm FF270R

Detaching the clamping arm from the fixation gear FF266R/FF267R/FF268R ► Pull the flexible clamping arm 5 out of the fixation gear 8 in the direction of the arrow, see Fig. F. Detaching the clamping arm from the coupling head FF282R/FF283R/FF284R ► Undo the flap screw 17 of the coupling head 16 and pull the flexible clamping arm 5 out of the coupling head 16, see Fig. J.

2.5.3

Fixation gear FF266R/FF267R/FF268R

Removing the fixation gear from rod/skull ► Undo the wing screw 21 and carefully remove the fixation gear 8 from the rod or skull cap, see Fig. K.

2.5.4

Coupling head FF282R/FF283R/FF284R

Removing the coupling head from the support arm ► Undo the clamping screw 18 and remove coupling head 16 from the support arm 19, see Fig. J. Disassembling the coupling head ► Turn the clamping screw 18 until it comes completely out of the coupling head 16. ► Remove all flap screws 17 and variable position clamp 20 from coupling head by turning.

2.5.5

Spatula holder FF273R/FF274R

Detaching the spatula holder from the clamping arm ► Undo wing nut 6. ► Remove brain spatula or tray for swabs 15 from the spatula holder 7 and remove spatula holder 7 from the screw collet of the flexible clamping arm 5, see Fig. H.

3.6.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ When cleaning instruments

Chapter Manual cleaning/disinfection and subsection:

■ FF180R ■ FF273R–FF274R ■ FF282R–FF284R

■ Chapter Manual cleaning with immersion disinfection

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

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.

Manual cleaning with ultrasound and immersion disinfection

■ FF266R–FF268R

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.

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.ak-i.org, link to "AKI-Brochures", "Red brochure".

3.3

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.

3.4

Preparations at the place of use

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example. ► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

3.5

3.6

Cleaning/Disinfection

3.6.1

Product-specific safety information on the reprocessing method

Danger to the patient! FF161R/FF163R/FF165R/FF270R/FF431R must not be manually reprocessed. ► Reprocess FF161R/FF163R/FF165R/FF270R/FF431R only by manually pre-cleaning followed by cleaning in a mechanical washer/disinfector. Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for plastics and high-grade steel, – that do not attack softeners (e.g., in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable disinfection temperature of 95 °C.

ultrasound and immersion disinfection

cloth or medical compressed air Mechanical alkaline cleaning and thermal disinfection

■ FF180R ■ FF273R–FF274R

■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

Chapter Mechanical cleaning/disinfection and subsection:

■ Chapter Mechanical alkaline

■ Place products in the tray with

cleaning and thermal disinfection

their hinges open. Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that

■ FF282R–FF284R

is suitable for cleaning (avoiding rinsing blind spots).

■ Place instruments in the tray

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

■ Chapter Manual pre-cleaning with a brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

with their hinges open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FF161R ■ FF163R ■ FF165R ■ FF266R–FF268R ■ FF270R ■ FF431R 3.7

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ Place the product in a tray that is suitable for cleaning (avoiding rinsing blind spots).

■ Place instruments in the tray

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

with their hinges open.

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

3.7.1

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

-

-

-

-

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly. ► Open up product with hinges. ► Release the flexible clamping arm FF270R.

■ Chapter Manual cleaning with

■ Drying phase: Use a lint-free

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.

Chapter Manual cleaning/disinfection and subsection:

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

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.

■ Suitable cleaning brush ■ 20 ml disposable syringe ■ When cleaning instruments

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection 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 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.

3.7.2

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

-

RT

-

V

Drying

-

-

-

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 dis-

infection 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. 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.

3.8

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.

3.9

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.

3.9.1

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 dis-

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

3.9.2

Manual pre-cleaning with ultrasound and brush

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

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 dis-

infection 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.

3.9.3

Mechanical alkaline cleaning and thermal disinfecting

Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

► Process the implant in its system storage device. ► Place the implants on a tray that is suitable for cleaning (avoiding rinsing blind spots and damage).

I

Prerinse

<25/77

3

D–W

-

Machine type: single-chamber cleaning/disinfecting machine without ultrasound

II

Cleaning

55/131

10

FD-W

■ Concentrate, alkaline:

3.8.1

Mechanical alkaline cleaning and thermal disinfection

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

■ working solution 0.5% – pH = 11*

– pH = 13 – <5 % anionic surfactant

■ 0.5 % working solution

III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD–W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

– pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

In accordance with the program for the cleaning and disinfecting machine

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alcaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechanical cleaning/disinfecting.

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

3.10.1 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 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 Tech-

nical service.

3.10.2 Functional test CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► FF266R/FF267R/FF268R/FF270R/FF282R/FF283R/FF284R: Prior to function checks, lubricate the clamping screw and the rotary ring 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). ► FF431R/FF161R/FF163R/FF165R: Prior to function checks, lubricate the clamping element and the threaded bush 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), see lubrication points a. ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working properly (e.g. hinges, locks/latches, sliding parts etc.). ► Check rotating products (e.g. reusable drills and cutters) for bends and 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.

3.11 Packaging ► 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 contamination of the product during storage.

3.12 Steam sterilization Note Sterilize the product only with all clamping elements slackened. ► 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.

3.13 Storage ► Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.

4.

Maintenance and service

4.1

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.

4.2

Accessories / spare parts

Art. no.

Designation

FF180R

Tray for swabs

FF266R

Fixation gear for mounting on a rod for one support arm FF270R

FF267R

Fixation gear for mounting on the skull for one support arm FF270R

FF268R

Fixation gear for mounting on the skull for two support arms FF270R

FF273R

Spatula holder, single, for flat spatula

FF274R

Spatula holder, single, for spatula with round stem

FF282R

Coupling head for one to five support arm(s) FF270R

FF283R

Rotatable coupling head for one clamping arm FF270R

FF284R

Rotatable coupling head with side opening for one clamping arm FF270R

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. Note The user institution is obliged to reprocess the product before its disposal, see Validated reprocessing procedure. TA006481

2020-06

V6

Change No. 62752