S4 MIS Spyder Instrumentation

Available sizes Name

Sizes

Tissue Dilator

6 mm 10 mm 16.5 mm 20 mm 24 mm

Spyder Retractor C/C Blade

16.5x40 mm 16.5x50 mm 16.5x60 mm 16.5x70 mm 16.5x80 mm 16.5x90 mm 16.5x100 mm 16.5x110 mm

20x40 mm 20x50 mm 20x60 mm 20x70 mm 20x80 mm 20x90 mm 20x100 mm 20x110 mm

Spyder Retractor M/L Blade Cvd

7x40 mm 7x50 mm 7x60 mm 7x70 mm 7x80 mm 7x90 mm 7x100 mm

20x40 mm 20x50 mm 20x60 mm 20x70 mm 20x80 mm 20x90 mm 20x100 mm

Delta Blade

7x17x40 mm 7x19x50 mm 7x22x60 mm 7x24x70 mm 7x27x80 mm 7x29x90 mm 7x31x100 mm 7x34x110 mm

24x40 mm 24x50 mm 24x60 mm 24x70 mm 24x80 mm 24x90 mm 24x100 mm 24x110 mm

3

Aesculap® S4® MIS Spyder Instrumentation Safe handling and preparation CAUTION Federal law restricts this device to sale by or on order of a physician! ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Read, follow, and keep the instructions for use. ► Use the product only in accordance with its intended use, see Intended use. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Store any new or unused products in a dry, clean, and safe place. ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► 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.

Lower Frame and Cranial Caudal (C/C) Blade Insertion ► After inserting the final dilation diameter, select

the length of the cranial-caudal (C/C) retractor blades based on the depth indicator on the dilator. ► Insert the C/C blades into the assembled “lower” frame (ME302R, ME303R, ME304R) by loosening the grub screw, engaging the blades into the frame and then tightening the grub screw. ► Close the retractor, creating a tube from the blades. ► Slide blades over the final dilator, and remove the tissue dilator. ► Expand the lower arm of the retractor by rotating the thumb ratchets of the retractor. ► The blades of the lower retractor may be flared using the retractor rotator arms (ME380R). Insert the rotator arms into the retractor and rotate the arms inwards to flare blades.

WARNING

Safe operation

WARNING

Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

Mini-open frame disassembles or jams due to unsecured blades! ► When placing blades into the frame arms always finger-tighten the grub screw to fix each blade in place to ensure blades do not pop out during use. ► Do not force blade into the frame arm as this will cause it to jam and make it difficult to remove.

Dilation ► Dilate the paraspinal muscles starting with the

smallest diameter (6 mm) Tissue Dilator (ME389T) and work up to the diameter of the cranial-caudal (C/C) retractor blades you intend to use (16.5 mm, 20 mm, or 24 mm diameters). ► The dilator handle may be attached to each dilator if desired.

4

WARNING

Damage to the surrounding muscle and soft tissues by retractor blades! ► Do not over retract blades.

Upper Frame and Medial Lateral (M/L) Blade Insertion ► The M/L blades of the upper retractor may be

inserted in a similar fashion using the upper frame of the retractor. The upper retractor frame has gold anodization on the collar for easy identification. ► Place the upper retractor arm over the lower retractor arm and expand and flare the upper retractor in a similar fashion if desired.

WARNING

Frames may not nest correctly if not assembled in right order! ► For the mini-open procedure ensure that the lower frame (silver collar) is inserted first. ► If a second frame is to be used, insert the upper frame (gold collar) over and perpendicular to the lower frame, ensuring that the frames nest together correctly.

► To remove a blade, insert the retractor blade handle

into the blade notches and rotate the knob counter-clockwise. Loosen the grub screw and remove the blade. ► To insert a new blade, place the new blade in the retractor arm, tighten the grub screw and rotate the blade removal knob clockwise to disengage the tool.

WARNING

Inability to remove retractor blades due to pressure from retracted tissues! ► Always set the retractor blades back to their vertical position prior to removing them. ► Pressure exerted by the tissues on the blades can make retraction of the collar difficult. Use the Blade Arm Rotator to relax the pressure on the teeth under the collar while gently retracting the collar.

Blade Replacement ► Blade lengths and shapes may be changed in situ

through the use of the blade holding instrument (ME381R). ► Before removing any blades, release the force of the soft tissue on the retractor blades by returning them to their parallel position. ► Insert the rotator arm into the retractor, pull back on the collar and rotate the arm to the upright position. ► Re-inserting the final dilator will hold the soft tissue while the retractor blade is exchanged.

WARNING

Damage to Blade Holder Instrument or C/C blades due to over tightening knob! ► Over tightening the knob on the Blade Holder Instrument will put unnecessary load on the threads and jaws of the instrument and may cause expansion of the caudal cranial blades that makes removal or insertion of the blade in the Spyder frame arm impossible.

5

Aesculap® S4® MIS Spyder Instrumentation

Lighting

Blade Handle (ME381R):

► For additional visibility attach a light source to

► Hold the blade handle head upright.

either the C/C Blade Light Rod Clip (ME387R) or the M/L Blade Light Rod Clip (ME388R). For additional visibility, the medial blade and M/L light clip will provide the best visibility.

WARNING

Damage to the light clip due to overheating! ► Using a light source greater than 300 watts will lead to excessive heating of the light cable and light clip.

► Unscrew the nut on the shaft proximally towards

the handle. Nut disengages the threading on the shaft. ► Turn the knob on the bottom counter clockwise until the head/shaft detaches from the handle. ► Remove the head/shaft from the handle. ► Remove the knob from the handle. Table Arm Pivot Connection Block (ME381R): ► Unscrew nut from the threading on the shaft away

from the connector. ► Unscrew wheel from connection block.

Securing the Lower Frame If desired, the lower arms of the retractor can be attached to the table arm. ► Attach the table arm connection block (ME382R) to the retractor arm (ME304R). ► Attach table arm connection block (ME382R) to the table arm (FF280R) by sliding the (ME382R) into the collar and tighten the knob. The Spyder Retractor is now attached to the table arm assembly.

Disassembling Frame Arm (ME300R–ME303R): ► Remove any blades attached to the frame arm by

loosening the grub screw. ► Open ratchet lock and slide the Frame Arm off the

Mini-Open Frame Rack (ME304R). ► Remove the thumb ratchet from the Frame Arm. ► Unthread grub screw so that it remains in the hold-

ing arm but is completely disengaged from its threading. ► Retract and rotate the collar 180° so that it is held by the positive stop in the retracted position for cleaning.

6

Assembling Frame Arm (ME300R–ME303R): ► Screw grub screws until they fully engage their

threads. ► Insert thumb screws into the Frame Arm block. ► Engage Frame Arm onto the Mini-Open Frame Rack

(ME304R): – The Left and Right Upper Frame arms (gold collar) should be paired with one another. – The Right and Left Lower Frame arms (silver collar) should be paired with one another. – The arm of the Frame Arm should face away from the teeth on the rack. – The thumb screws should be on the distant ends of the rack, – The frame arms are facing inward. ► Retract the collar and rotate the arms until the concave frame faces inward, and the grub screws point out and upward.

Blade Handle (ME381R): ► Insert the knob into the slot on the bottom of the

handle. ► Insert the head/shaft until it engages the threads

inside the knob. ► Hold the blade handle head upright. ► Turn the knob clockwise until the head/shaft fully engages with the handle. ► Orient the head so that the pegs on the head will mesh with the slots on the handle. ► Ensure that the head is fully engaged with the handle. ► Thread the nut on the handle distally towards the head until it is fully threaded. ► Ensure the Blade Handle operates correctly by turning the knob counter clockwise to spread open the arms and clockwise to close the arms. Table Arm Pivot Connection Block (ME381R): ► Thread the wheel onto the block until it is fully

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. The recommended chemistry was used for validation. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For the latest information on reprocessing and material compatibility see also the Aesculap extranet at www.extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

engaged. ► Thread the nut on the shaft towards the connector

until it is fully engaged.

Validated reprocessing procedure 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.

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.

7

Aesculap® S4® MIS Spyder Instrumentation

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 Publications, Red Brochure – Proper maintenance of instruments.

Disassembling the product before carrying out the reprocessing procedure ► Disassemble the product immediately after use, as

described in the respective instructions for use. ► Open up products with hinges.

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.

Preparation before cleaning ► Disassemble the product prior to cleaning, see Dis-

assembling.

8

Cleaning/disinfection Product-specific safety notes on the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Use cleaning and disinfecting agents according to the manufacturer’s instructions which are approved for (e.g. titanium, highgrade steel). ► Observe specifications regarding concentration, temperature and exposure time.

► Use suitable cleaning/disinfecting agents if the

product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water. ► Carry out ultrasound cleaning: – as an effective mechanical supplement to manual cleaning/disinfecting. – as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/disinfecting. – as an integrated mechanical support measure for mechanical cleaning/disinfecting. – for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection ME389T–ME393T ME394T ME304R ME380R ME319T–ME326T ME327T–ME334T ME335T–ME341T ME350T–ME356T ME357T–ME364T ME387R ME388R

■ Cleaning brush: e.g. TA011944 ■ Disposable syringe 20 ml ■ When cleaning products with

Chapter Manual cleaning/disinfection and sub-chapter: ■ Chapter Manual cleaning with immersion disinfection

Manual cleaning with ultrasound and immersion disinfection ME300R ME301R ME302R ME303R ME381R ME382R

■ Cleaning brush: TA011944,

Mechanical alkaline cleaning and thermal disinfection ME304R ME380R ME319T–ME326T ME387R ME388R

■ Place the product in a tray that is

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

TE654202, or GK469200

■ Disposable syringe 20 ml ■ When cleaning products with

Chapter Manual cleaning/disinfection and sub-chapter: ■ Chapter Manual cleaning with ultrasound and immersion disinfection

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

suitable for cleaning (avoiding rinsing blind spots).

■ Place products in the tray with

Chapter Mechanical cleaning/disinfecting and sub-chapter: ■ Chapter Mechanical alkaline cleaning and thermal disinfecting

their hinges open.

9

Aesculap® S4® MIS Spyder Instrumentation

Validated procedure

Specific requirements

Reference

Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection ME389T–ME394T** ME327T–ME334T ME335T–ME341T ME350T–ME356T ME357T–ME364T

■ Cleaning brush: e.g. TA011944,

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

TE654202, or GK469200

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

■ **Connect components with

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

lumens and channels directly to the rinsing port of the injector carriage.

■ Keep working ends open for cleaning.

■ Place products in the tray with their hinges open. Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection ME300R ME301R ME302R ME303R ME381R ME382R

■ Cleaning brush: e.g. TA011944, TE654202, or GK469200

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

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

■ Keep working ends open for cleaning.

■ Place products in the tray with their hinges open.

10

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter: ■ Chapter Manual pre-cleaning with ultrasound and brush

■ Chapter Mechanical alkaline cleaning and thermal disinfecting

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.

Manual cleaning and wipe disinfecting Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

-

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

Phase I

Phase III

► Clean the product under running faucet water,

► Wipe all surfaces of the product with a single-use

using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable

disinfectant wipe. Phase IV ► After the specified exposure time (at least 1 min),

rinse the disinfected surfaces under running FD water. ► Drain any remaining water fully.

equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

11

Aesculap® S4® MIS Spyder Instrumentation

Phase V ► Dry the product in the drying phase with suitable

equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

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)

15

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 ► Note the information on appropriate cleaning

► Mobilize non-rigid components, such as set screws,

brushes and disposable syringes, see Validated cleaning and disinfection procedure.

► Thoroughly rinse through these components with

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.

12

links, etc. during cleaning. 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.

► Mobilize non-rigid components, such as set screws,

Phase III

joints, etc. during final rinse.

► Fully immerse the product in the disinfectant solu-

► Rinse lumens with an appropriate disposable

tion. ► 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.

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 IV ► Rinse/flush the product thoroughly (all accessible

surfaces).

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)

15

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 ► Note the information on appropriate cleaning

brushes and disposable syringes, see Validated cleaning and disinfection procedure.

13

Aesculap® S4® MIS Spyder Instrumentation

Phase I

Phase IV

► Clean the product in an ultrasonic cleaning bath

► Rinse/flush the product thoroughly (all accessible

(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 solu-

tion. ► 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.

14

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.

Mechanical cleaning/disinfecting 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.

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/Note

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 disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechani-

cal cleaning/disinfecting.

15

Aesculap® S4® MIS Spyder Instrumentation Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device 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

Neutral: ■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline: ■ Concentrate: – pH = 9.5 – <5 % anionic surfactant ■ 0.5 % 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

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechani-

cal cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if neces-

sary.

16

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.

Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfectant 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 ► 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-

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.

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.

17

Aesculap® S4® MIS Spyder Instrumentation Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

18

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

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 disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline ► Check visible surfaces for residues after mechani-

cal cleaning/disinfecting.

19

Aesculap® S4® MIS Spyder Instrumentation Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device 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

Neutral: ■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline: ■ Concentrate: – pH = 9.5 – <5 % anionic surfactant ■ 0.5 % 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

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechani-

cal cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if neces-

sary.

20

Inspection, maintenance and checks

CAUTION

Damage (metal seizure/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: Aesculap STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room tempera-

ture. ► After each complete cleaning, disinfecting and dry-

ing cycle, check that the product is dry, clean, operational, and free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components). ► Dry the product if it is wet or damp. ► Repeat cleaning and disinfection of products that still show impurities or contamination. ► Check that the product functions correctly. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service. ► Assemble dismountable products, see Assembling. ► Check for compatibility with associated products.

Packaging ► 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 all cutting edges are protected. ► Pack trays appropriately for the intended steriliza-

tion process (e.g. in Aesculap sterile containers). ► Ensure that the packaging provides sufficient pro-

tection against recontamination of the product during storage.

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 product with the lock fully open or locked no further than on the first ratchet tooth. ► Check to ensure that the sterilizing agent will come

into contact with all external and internal surfaces (e.g. by opening any valves and faucets). ► Validated sterilization process: – Disassemble the product – Steam sterilization through fractionated 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 ► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity of the steam sterilizer specified by the manufacturer is not exceeded.

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