TSPACE PEEK(3rd generation) TSPACE XP TSPACE 3D – Instruments

A 1

2

B 7

6

C

D

E

F

5

3

4

en

AESCULAP® TSPACE® PEEK(3rd generation) /TSPACE® XP / TSPACE® 3D Instruments Legend A Insertion instrument SN305R (assembled) B Insertion instrument SN305R (disassembled): 1 Tube 2 Switch 3 Rotary nut 4 Irrigation connector 5 Pin 6 Rod 7 Dihedron C Slap hammer SN320R D Trial implant E Packing block SN304R F Packing block SN704R

Contents 1. 1.1 1.2 2. 2.1 2.1.1 2.1.2 2.1.3 2.2 2.2.1 2.2.2 2.2.3 2.3 2.3.1 2.3.2 2.3.3 3. 3.1 3.2 3.3 3.4 3.5 2

About this document... 3 Scope... 3 Safety messages... 4 Clinical use... 4 Areas of use and limitations of use... 4 Intended use... 4 Indications... 4 Contraindications... 4 Safety information... 4 Clinical user... 4 Product... 5 Sterility... 5 Application... 5 Preparing the implant bed... 5 Determining the implant height with the trial implant... 5 Inserting the implant in the implant bed. . 7 Validated reprocessing procedure... 9 General safety information... 9 General information... 9 Reusable products... 10 Preparations at the place of use... 10 Preparing for cleaning... 10

3.6 3.7 3.7.1 3.7.2 3.8 3.8.1 3.8.2 3.9 3.9.1 3.10 3.10.1 3.10.2 3.10.3 3.11 3.11.1 3.11.2 3.12 3.13 3.14 3.15 4. 5. 6.

Disassembly... 10 Cleaning/Disinfection... 10 Product-specific safety information on the reprocessing method... 10 Validated cleaning and disinfection procedure... 11 Manual cleaning/disinfection... 11 Manual cleaning with immersion disinfection... 12 Manual cleaning with ultrasound and immersion disinfection... 13 Mechanical cleaning/disinfection... 14 Mechanical alkaline cleaning and thermal disinfection... 14 Mechanical cleaning/disinfection with manual pre-cleaning... 15 Manual pre-cleaning with a brush... 15 Manual pre-cleaning with ultrasound and brush... 16 Mechanical alkaline cleaning and thermal disinfecting... 17 Inspection... 18 Visual inspection... 18 Functional test... 18 Assembly... 18 Packaging... 18 Steam sterilization... 18 Storage... 18 Technical service... 19 Disposal... 19 Symbols on product and packaging... 19

en 1.

About this document

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

TSPACE PEEK/TSPACE XP/TSPACE 3D trial implants 30 mm Art. no.

Designation

SN352R

Trial implant 5° 30 x 11.5 x 7 mm

These instructions for use apply for the following products:

SN353R

Trial implant 5° 30 x 11.5 x 8 mm

SN354R

Trial implant 5° 30 x 11.5 x 9 mm

Art. no.

Designation

SN355R

Trial implant 5° 30 x 11.5 x 10 mm

SN304R

TSPACE PEEK/TSPACE XP packing block

SN356R

Trial implant 5° 30 x 11.5 x 11 mm

SN305R

TSPACE PEEK/TSPACE XP insertion instrument

SN357R

Trial implant 5° 30 x 11.5 x 12 mm

SN358R

Trial implant 5° 30 x 11.5 x 13 mm

SN320R

TSPACE PEEK/TSPACE XP slap hammer

SN359R

Trial implant 5° 30 x 11.5 x 14 mm

SN704R

TSPACE 3D packing block

1.1

Scope

SN360R

Trial implant 5° 30 x 11.5 x 15 mm

TSPACE PEEK/TSPACE XP/TSPACE 3D trial implants 26 mm

SN362R

Trial implant 5° 30 x 11.5 x 17 mm

Art. no.

Designation

TSPACE PEEK/TSPACE XP/TSPACE 3D trial implants 34 mm

SN322R

Trial implant 5° 26 x 11.5 x 7 mm

Art. no.

Designation

SN323R

Trial implant 5° 26 x 11.5 x 8 mm

SN382R

Trial implant 5° 34 x 11.5 x 7 mm

SN324R

Trial implant 5° 26 x 11.5 x 9 mm

SN383R

Trial implant 5° 34 x 11.5 x 8 mm

SN325R

Trial implant 5° 26 x 11.5 x 10 mm

SN384R

Trial implant 5° 34 x 11.5 x 9 mm

SN326R

Trial implant 5° 26 x 11.5 x 11 mm

SN385R

Trial implant 5° 34 x 11.5 x 10 mm

SN327R

Trial implant 5° 26 x 11.5 x 12 mm

SN386R

Trial implant 5° 34 x 11.5 x 11 mm

SN328R

Trial implant 5° 26 x 11.5 x 13 mm

SN387R

Trial implant 5° 34 x 11.5 x 12 mm

SN329R

Trial implant 5° 26 x 11.5 x 14 mm

SN388R

Trial implant 5° 34 x 11.5 x 13 mm

SN330R

Trial implant 5° 26 x 11.5 x 15 mm

SN389R

Trial implant 5° 34 x 11.5 x 14 mm

SN332R

Trial implant 5° 26 x 11.5 x 17 mm

SN390R

Trial implant 5° 34 x 11.5 x 15 mm

SN392R

Trial implant 5° 34 x 11.5 x 17 mm

3

en TSPACE 3D trial implants 38 mm

2.

Clinical use

Art. no.

Designation

2.1

Areas of use and limitations of use

SN783R

Trial implant 5° 8 x 11.5 x 38 mm

2.1.1

Intended use

SN784R

Trial implant 5° 9 x 11.5 x 38 mm

SN785R

Trial implant 5° 10 x 11.5 x 38 mm

SN786R

Trial implant 5° 11 x 11.5 x 38 mm

SN787R

Trial implant 5° 12 x 11.5 x 38 mm

SN788R

Trial implant 5° 13 x 11.5 x 38 mm

SN790R

Trial implant 5° 15 x 11.5 x 38 mm

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 and material

compatibility and lifetime information, B. Braun eIFU at eifu.bbraun.com

1.2

see

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.

4

The TSPACE PEEK/TSPACE XP/TSPACE 3D instruments are used to insert TSPACE PEEK (third generation), TSPACE XP and TSPACE 3D trial implants and implants into the thoracolumbar spine. The SN305R insertion instrument is used for implanting implants and for determining the implant size by inserting trial implants into the intervertebral space. The slap hammer SN320R is coupled to the insertion instrument. The slap hammer is used to expel the trial implants from the intervertebral space or to revise the implants. The packing blocks SN304R (for TSPACE PEEK (3rd generation) / TSPACE XP) and SN704R (for TSPACE 3D) are used to hold the implants on the surgical table while filling the inner window with bone material.

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.

en ► Prior to use, check that the product is in good work-

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

2.2.2

Product

Product-specific safety information ► Only use the product with visual control.

2.2.3

2.3.1

Preparing the implant bed

WARNING Risk of injury to nerves, blood vessels, and tissue caused by sharp instruments! ► To avoid injuries, proceed with extreme care during the operation. ► Resect the facet joint. ► Open the intervertebral disk space. ► Restore the height of the intervertebral disk using

distractors. ► Clear the intervertebral disk space using rongeurs,

sharp spoons and curettes. ► If necessary, apply bone material.

2.3.2

Determining the implant height with the trial implant

Pick up the trial implant with the insertion instrument ► Turn the rotary nut 3 on the insertion instrument A counterclockwise (“loosen” direction) to push the rod 6 forward, see Fig. 1.

256

3

Sterility

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

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. Fig. 1

Close-up view of the insertion instrument, switch open

5

en ► Couple the trial implant D to the dihedron 7 on the

insertion instrument, A see Fig. 2. When doing so, pay attention to the orientation of the trial implant (orientation according to the marking on the insertion instrument). ► Use the insertion instrument SN305R or SN705R for TSPACE PEEK / TSPACE XP / TSPACE 3D trial implants. Refer to TA015946 for application instructions for SN705R.

7

► Hold the trial implant D at 0° position on the inser-

tion instrument A, see Fig. 8. ► Turn the rotary nut 3 on the insertion instrument A

clockwise (“tighten” direction) until the trial implant is clamped, see Fig. 4.

2 5

3

A

Fig. 4

D

Close-up view of the insertion instrument, trial implant/implant clamped

► Check manually that the trial implant is securely in

place.

Fig. 2

Coupling the trial implant to the insertion instrument

Note The switch 2 can only be turned when the rod is in the front position and the pin 5 is fully visible in the switch. ► Turn the switch 2 to the right (direction

), see

Fig. 3.

2 5

Fig. 3

6

3

Close-up view of the insertion instrument, switch closed

Inserting the trial implant ► Insert the trial implant D with the insertion instrument 1 straight (0° position) into the prepared implant bed. To do so, carefully hit with a hammer on the impact surface of the rotary nut 3. ► To turn the trial D implant: – Gently turn the rotary nut 3 counterclockwise (“loosen” direction). When doing so, make certain that the pin 5 remains outside of the switch 2. – Impact the trial implant D further with the hammer until the required end position is reached. ► Check the position of the trial implant D using intraoperative X-ray control.

en 2.3.3

Removing the trial implant ► Mounting the slap hammer C onto the insertion

instrument A, see Fig. 5.

A C Fig. 5

Mounting the slap hammer onto the insertion instrument

► Carefully expel the trial implant D using the slap

hammer C out of the intervertebral space, see Fig. 6.

Inserting the implant in the implant bed

Picking up the implant with the insertion instrument ► Select an implant according to the size of the trial implant. ► Remove the implant with protective packaging from the sterile packaging. ► Mount the implant a in the protective packaging onto the dihedron 7 of the insertion instrument A, see Fig. 7. When doing so, pay attention to the orientation of the implant (orientation according to the marking on the insertion instrument). ► Use the insertion instrument SN305R or SN705R for TSPACE PEEK / TSPACE XP / TSPACE 3D implants. Refer to TA015946 for application instructions for SN705R.

C

a Fig. 6

7

A

Expelling the trial implant/implant with the slap hammer

► Uncoupling the slap hammer C from the insertion

instrument A. Uncoupling the trial implant from the insertion instrument ► Turn the rotary nut 3 counterclockwise ("loosen" direction), until the pin 5 is fully in the switch 2, see Fig. 3. When doing so, ensure that the pin 5 does not jam the switch 2. ► Turn the switch 2 to the left (direction ), see Fig. 1. ► Remove the trial implant. ► If necessary, repeat the process with the next biggest trial implant, until the correct implant size is determined.

Fig. 7

Coupling the implant to the insertion instrument

Legend a Implant ► Turn the switch 2 to the right (direction

), see

Fig. 3. ► Hold the implant at 0° position, see Fig. 8.

a Fig. 8

7

A

Implant at 0° position

► Turn the rotary nut 3 on the insertion instrument A

clockwise (:“tighten” direction) until the trial implant is clamped, see Fig. 4. ► Remove the protective packaging from the implant. ► Check manually that the implant is securely in place. 7

en Filling the implant with bone material (optional) ► Place implant a in packing block E (PEEK and XP) or F (3D), see Fig. 9. When doing so, observe the implant length (markings on the packing block indicate lengths).

E

► To turn the implant a:

– Gently turn the rotary nut 3 counterclockwise (“loosen” direction). When doing so, make certain that the pin 5 remains outside of the switch 2. – Impact the implant a further with the hammer until the required end position is reached. ► Check the position of the implant a using intraoperative X-ray control. ► Once the end position (see Fig. 11) is reached: turn the rotary nut 3 counterclockwise ("loosen" direction), until the pin 5 is fully in the switch 2, see Fig. 3. When doing so, ensure that the pin 5 does not jam the switch 2.

a

a a

A

A

Fig. 9

Implant in packing block

Fig. 11 Implant in end position

► Compress the bone grafts or bone replacement

material in the inner window of the implant a using the punch (tamper) provided in the set. When doing so, ensure that the punch (tamper) does not damage the surface of the implant. Inserting the implant the implant a with the insertion instrument A straight (0° position) into the prepared implant bed. To do so, carefully hit with a hammer on the impact surface of the rotary nut 3.

► Insert

a a A

Fig. 10 Inserting the implant into the implant bed

8

A

► Turn the switch 2 to the left (direction

), see Fig. 1. ► Carefully remove the insertion instrument A from the implant a. Avoid any tilting or canting of the instrument when doing so. ► Place bone or bone replacement material around the implant a. Removing the implant intraoperatively If, in the opinion of the surgeon, it becomes necessary to remove the implant intraoperatively, carry out the following steps: ► Check the position for coupling the insertion instrument A, see Fig. 1. ► Couple insertion instrument A to implant a in situ, see Fig. 7. ► Turn the switch 2 to the right (direction ), see Fig. 3. ► Mounting the slap hammer B onto the insertion instrument A, see Fig. 5. ► Carefully expel the implant a using the slap hammer C out of the intervertebral space, see Fig. 6.

en 3. 3.1

Validated reprocessing procedure General safety information

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products. Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. Note Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note For up-to-date information about reprocessing and material compatibility, see B. Braun eIFU at eifu.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating 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".

9

en 3.3 Reusable products ■ There is no set maximum number of uses and preparation cycles for the product. ■ The life of the product is limited by damage, normal wear and tear, type and duration of use, as well as handling, storage and transport of the product. ■ A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional.

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

Preparing for cleaning

► Disassemble the product prior to cleaning, see Dis-

assembly. ► For mechanical cleaning: mount the irrigation

connector 4 to the rear end of the rotary nut 3.

3.6

Disassembly

SN305R insertion instrument ► Turn the rotary nut 3 counterclockwise (“loosen” direction). ► Turn the switch 2 to the left (direction

), see Fig. 1. ► Turn the rotary nut 3 clockwise (“tighten“ direction), until the rod 6 is out of the thread. ► Remove the rod 6 from the tube 1, see Fig. 12.

1 6 Fig. 12 Insertion instrument disassembled

10

3.7

Cleaning/Disinfection

3.7.1

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 plastic material and highgrade 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 put away 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 ► SN304R/SN704R packing block: manually preclean the product (with a cleansing brush) if there are residues of bone, tissue or ancillary materials (such as plaster or bone cement).

en 3.7.2

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Manual cleaning with immersion disinfection ■ SN304R

Chapter Manual cleaning/disinfection and ■ Suitable cleaning brush subsection: ■ 20 ml disposable syringe ■ Chapter Manual cleaning with immer■ Drying phase: Use a lint-free cloth or sion disinfection

■ SN704R ■ Trial implants Manual cleaning with ultrasound and immersion disinfection ■ SN305R

■ SN320R Mechanical alkaline cleaning and thermal disinfection ■ SN304R

Reference

medical compressed air

Chapter Manual cleaning/disinfection and ■ Suitable cleaning brush subsection: ■ 20 ml disposable syringe ■ Chapter Manual cleaning with ultra■ Drying phase: use a lint-free cloth or sound and immersion disinfection medical compressed air

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

Chapter Mechanical cleaning/disinfection and subsection: ■ Chapter Mechanical alkaline cleaning and thermal disinfection

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

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

■ SN704R Manual pre-cleaning with brush and subsequent mechanical alkaline cleaning and thermal disinfection ■ SN320R

suitable for cleaning (avoid rinsing blind spots).

■ Trial implants Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection ■ SN305R

3.8

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

■ Chapter Mechanical alkaline cleaning and thermal disinfecting 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

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.

11

en 3.8.1

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-

Phase III ► Fully immerse the product in the disinfectant solu-

tion. ► 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.

► Rinse lumens at least 5 times at the beginning of

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.

► Dry the product in the drying phase with suitable

12

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

en 3.8.2

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: 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

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. 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.

surfaces) under running water. ► Mobilize non-rigid components, such as set screws,

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

13

en 3.9

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.

3.9.1

Mechanical alkaline cleaning and thermal disinfection

Machine type: single-chamber cleaning/disinfecting machine 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

DW: 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 mechanical

cleaning/disinfecting.

14

en 3.10 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.

3.10.1 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 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.

15

en 3.10.2 Manual pre-cleaning with ultrasound and brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

D–W: Drinking water RT: Room temperature *Recommended: BBraun Stabimed fresh ► Note the information on appropriate cleaning

brushes and disposable syringes, see Validated cleaning and disinfection procedure. Phase I ► Clean the product in an ultrasonic cleaning bath

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

surfaces) under running water. ► Mobilize non-rigid components, such as set screws,

joints, etc. during rinsing.

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en 3.10.3 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

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: 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.

17

en 3.11 Inspection ► Allow the product to cool down to room tempera-

ture. ► Dry the product if it is wet or damp.

3.11.1 Visual inspection ► Ensure that all soiling has been removed. In partic-

ular, pay attention to mating surfaces, hinges, shafts, recessed areas, drill grooves and the sides of the teeth on rasps. ► If the product is dirty: repeat the cleaning and disinfection process. ► Check the product for damage, e.g. insulation or corroded, loose, bent, broken, cracked, worn or severely scratched and fractured components. ► Check the product for missing or faded labels. ► Check the products with long, slim shapes (in particular rotating instruments) for deformities. ► Check the surfaces for rough spots. ► Check the product for burrs that could damage tissue or surgical gloves. ► Check the product for loose or missing parts. ► Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical service.

3.11.2 Functional test CAUTION Damage (metal cold welding /friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598).

3.12 Assembly SN305R insertion instrument ► Turn the switch 2 to the left (direction ). ► Insert the rod 6 into the tube 1, see Fig. 12. ► Turn the rotary nut 3 counterclockwise (“loosen” direction) to push the rod 6 forward, see Fig. 1.

3.13 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 pro-

tection against contamination of the product during storage.

3.14 Steam sterilization Note SN305R insertion instrument may only be sterilized in disassembled state. ► 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 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.

► Assemble disassembled products, see Assembly.

3.15 Storage

► Check that the product functions correctly.

► Store sterile products in germ-proof packaging,

► Check that all moving parts are working property

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

18

protected from dust, in a dry, dark, temperaturecontrolled area.

en 4.

Technical service

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

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.

6.

Symbols on product and packaging Implant coupled

Implant uncoupled

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