SecureSpan – Instruments

A

E

B

F

C

G

D

H

I

J

L

M

K

en

Aesculap® SecureSpan Instruments Legend A B C D E F G H I J K L M

Trial implants FG836R-FG840R Lamina lifter FG847R Locking screwdriver FG848R Implant holder FG849R Plate holder FG851R Drill handle FG861R Depth gauge FG866R Bone awl FG867R Adjustable single drill guide FG868R Fixed depth drills FG856SU to FG860SU & FG842SU Drill FG869SU for use with drill guide Plate bending pliers LX185R Plate cutters LX159R

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 2.3.4 2.3.5 3. 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.7.1 3.7.2 3.7.3 3.8 3.8.1 3.8.2

2

About this document... Scope... Safety messages... Clinical use... Areas of use and limitations of use... Intended use... Indications... Contraindications... Safety information... Clinical user... Product... Sterility... Application... Selecting the right plate length for the SecureSpan plate... Adapting the SecureSpan plate... Preparing the holes for the SecureSpan screws... Inserting the screws... Removing SecureSpan implants... Validated reprocessing procedure... General safety instructions... General information... Single-use products... Reusable products... Preparations at the place of use... Preparing for cleaning... Disassembly... Single drill guide FG868R... Depth gauge FG866R... Screwdriver FG848R... Cleaning/Disinfection... Product-specific safety information on the reprocessing method... Validated cleaning and disinfection procedure...

2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 6 6 7 7 7

3.9 3.9.1 3.9.2 3.10 3.10.1 3.11 3.11.1 3.11.2 3.11.3 3.12 3.12.1 3.12.2 3.13 3.13.1 3.13.2 3.13.3 3.14 3.15 3.16 4. 5.

Manual cleaning/disinfection... 8 Manual cleaning with immersion disinfection... 8 Manual cleaning with ultrasound and immersion disinfection 9 Mechanical cleaning/disinfection... 10 Mechanical alkaline cleaning and thermal disinfecting... 10 Mechanical cleaning/disinfection with manual pre-cleaning. 11 Manual pre-cleaning with a brush... 11 Manual pre-cleaning with ultrasound and brush... 11 Mechanical alkaline cleaning and thermal disinfecting... 12 Inspection... 12 Visual inspection... 12 Functional test... 12 Assembly... 13 Single drill guide FG868R... 13 Depth gauge FG866R... 13 Screwdriver FG848R... 13 Packaging... 13 Steam sterilization... 13 Storage... 13 Technical service... 13 Disposal... 13

1.

About this document

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

1.1

Scope

These instructions for use apply for the products listed in the Legend above. Note The applicable CE mark for the product can be seen on the label or packaging of the product. ► For article-specific instructions for use as well as information on mate-

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

1.2

Safety messages

Safety messages make clear the dangers to patient, user and/or product that could arise during the use of the product. Safety messages are labeled as follows: 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.

en 2.

Clinical use

2.1

Areas of use and limitations of use

2.2.3

Sterility

2.1.1 Intended use The SecureSpan Laminoplasty Plating system includes the instruments listed in the Legend above. These instruments are used to place the plates and screws to stabilize the lamina after a laminectomy procedure has been performed.

Non-sterile packaged products Art. no.

Designation

FG836R to FG840R

Trial implants

FG847R

Lamina lifter

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.

FG848R

Locking screwdriver

FG849R

Implant holder

FG851R

Plate holder

For indications, see Intended use.

FG861R

Drill handle

FG866R

Depth gauge

FG867R

Bone awl

FG868R

Adjustable single drill guide

LX185R

Plate bending pliers

LX159R

Plate cutters

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

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

Designation

FG856SU to FG860SU Fixed depth drills FG842SU FG869SU

Drill for use with drill guide

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

The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

Product

Product-specific safety information The operating surgeon must be thoroughly conversant with stabilization techniques for and the biomechanical properties of the cervical spine. He must also be familiar with the theory and practice of operative techniques within the SecureSpan system. ► Always follow the instructions for use of the SecureSpan plates and screws (TA013082) and the surgical technique guide. ► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. drill).

3

en 2.3

Application

WARNING Risk of injury and/or malfunction! ► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components. ► Always carry out a function test prior to each use of the product. 2.3.1

Selecting the right plate length for the SecureSpan plate

► Use the Trial implants A to select the appropriate plate and spacer size.

2.3.2 Adapting the SecureSpan plate The SecureSpan plates supplied by Aesculap are supplied as pre-bent implants. They can be bent by means of the plate benders. Further bending should be done at the existing bends. CAUTION Damage to the SecureSpan implant through excessive strain on the material! ► Always bend the SecureSpan plate in one direction only. ► Do not bend back the SecureSpan plate. ► Avoid small bending radii, bending back, notching or scratching the

SecureSpan plate. 2.3.3 Preparing the holes for the SecureSpan screws The holes for the self-tapping SecureSpan screws are either created using the awl H, or the fixed depth drills J, or the drill K and drill guide I. The drills can be driven manually with drill handle F or with a motor system and Aesculap Intra handpiece (e.g., GD450R/GD456R). CAUTION Risk of drilling into the patient's spinal cord as a result of the cutting depth set incorrectly on the drill guide! ► Insert the drill into the drill guide and check the set cutting depth with a caliper or ruler.

Note The maximum center punch depth with the awl H is 3 mm. Do not use the awl with the drill guide. ► To adjust the required depth with the depth-adjustable drill guide I

(0 mm to 14 mm), turn guide sleeve 1 of the drill guide in direction “+” or “-”. Note that the thread of the drill guide is a left-handed type. Every half-turn (= height adjustment by 0.5 mm) you will hear and feel the guide sleeve clicking into position. 2.3.4

Inserting the screws

CAUTION Damage to the SecureSpan plate or SecureSpan screw in the course of driving the screw into the bone through the plate, caused by incorrectly applied screwdriver! ► Fully insert the tip of the screwdriver into the cross slot of the screw. ► Lock the screwdriver to the screw through clockwise turning of the thumbwheel. CAUTION Damage to the locking thread of the SecureSpan screw, or the screwdriver tip caused by overtorquing the locking thread! ► Ensure that the SecureSpan screw is firmly attached to the screwdriver. Note The locking screwdriver C has a self-holding feature. A screw holding sleeve is not necessary.

3

2 4

1 Fig. 2 ► Fully insert the tip 2 of the locking screwdriver C into the screw

head 3. ► Tighten the thumbwheel 4 clockwise until hand-tight. ► Apply gentle pressure on the locking screwdriver C while driving the

SecureSpan screw into bone through the hole of the SecureSpan plate until seated. ► Detach the locking screwdriver C from the screw head by turning the thumbwheel 4 counterclockwise.

Fig. 1

4

Drill attached to drill handle through drill guide

en 2.3.5 Removing SecureSpan implants ► Always use SecureSpan instruments to remove SecureSpan implants. Note The screwdriver C can also be used for screw removal.

10 mm

Fig. 3

5

6

7

8

Using the depth gauge FG866R

► Using the depth gauge G with a SecureSpan plate 5 for the measuring

example 6 of a 10 mm SecureSpan screw: – Loosen knurled nut 7. – Slide caliper 8 of depth gauge G in the required direction (e.g., 10 mm, see Fig. 3). – Tighten knurled nut 7. The depth gauge is fixed at the measured depth of 10 mm.

3.

Validated reprocessing procedure

3.1

General safety instructions

Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing. Note For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of products.

3.2

General information

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the time interval between application and processing should not exceed 6 h; also, neither fixating precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used. Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the laser marking becoming unreadable visually or by machine for stainless steel. Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water and then drying. Additional drying, if necessary. Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes. ■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling. ► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, link to "AKIBrochures", "Red brochure".

3.3

Single-use products

Art. no.

Designation

Note Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results.

FG856SU to FG860SU Fixed depth drills FG842SU

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.

► Do not reuse the product. The reprocessing of the product affects its functionality. Risk of injury, illness or death due to soiling and/or impaired functionality of the product. ► Do not reprocess the product.

FG869SU

Drill for use with drill guide

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.

5

en 3.4

Reusable products

Art. no.

Designation

FG836R to FG840R

Trial implants

FG847R

Lamina lifter

FG848R

Locking screwdriver

FG849R

Implant holder

FG851R

Plate holder

FG861R

Drill handle

FG866R

Depth gauge

FG867R

Bone awl

FG868R

Adjustable single drill guide

LX185R

Plate bending pliers

LX159R

Plate cutters

Influences of the reprocessing which lead to damage to the product are not known. A careful visual and functional inspection before the next use is the best opportunity to recognize a product that is no longer functional, see Inspection.

3.5

3.7

Disassembly

3.7.1

Single drill guide FG868R

1

Fig. 4 ► Remove guide sleeve 1 by turning it clockwise. Be aware that it is a

left-hand thread. You will hear and feel the guide sleeve clicking into position every half turn. 3.7.2

Depth gauge FG866R

Preparations at the place of use

7

8

► 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

8

damp, lint-free cloth. ► Transport the dry product in a sealed waste container for cleaning and

7

disinfection within 6 hours.

3.6

Preparing for cleaning

► Disassemble the product prior to cleaning, see Disassembly.

Fig. 5 ► Loosen knurled nut 7. ► Extract caliper 8 in the direction of the arrow. ► Unscrew and remove knurled nut 7.

3.7.3

Screwdriver FG848R

10

9

Fig. 6 ► Unscrew locking nut 9 of locking screwdriver C clockwise. ► Slide outer shaft 10 of the distal tip of locking screwdriver C.

6

en 3.8

Cleaning/Disinfection

3.8.1

Product-specific safety information on the reprocessing method Damage to or destruction of the product due to inappropriate cleaning/disinfecting agents and/or excessive temperatures! ► Following the manufacturer's instructions, use cleaning and disinfecting agents – that are approved for high-grade steel, – that do not attack softeners (e.g., in silicone).

3.8.2

► Observe specifications regarding concentration, temperature and

exposure time. ► Do not exceed the maximum allowable disinfection temperature of

95 °C. ► Use suitable cleaning/disinfecting agents if the product is disposed of

in a wet condition. To prevent foaming and degradation of the efficacy of the process chemicals: prior to mechanical cleaning and disinfection, rinse the product thoroughly with running water

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion disinfection

■ Suitable cleaning brush: e.g., TA006874 and TE654202 ■ Disposable syringe 20 ml ■ Drying phase: Use a lint-free cloth or medical compressed air

Chapter Manual cleaning/disinfection and subsection:

■ Suitable cleaning brush: e.g., TA006874 and TE654202 ■ Disposable syringe 20 ml ■ Drying phase: Use a lint-free cloth or medical compressed air

Chapter Manual cleaning/disinfection and subsection:

■ FG836R to FG840R ■ FG847R to FG848R ■ FG866R to FG868R Manual cleaning with ultrasound and immersion disinfection

■ FG849R ■ FG851R ■ FG861R ■ LX159R ■ LX185R

■ Chapter Manual cleaning with immersion disinfection

■ Chapter Manual cleaning with ultrasound and immersion disinfection

Mechanical alkaline cleaning and thermal disinfection

■ Place the product in a tray that is suitable for cleaning (avoiding rins- Chapter Mechanical cleaning/disinfec-

■ FG836R to FG840R ■ FG847R ■ FG867R

■ Connect components with lumens and channels directly to the rins- ■ Chapter Mechanical alkaline clean-

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

Chapter Mechanical cleaning/disinfec■ Suitable cleaning brush tion with manual pre-cleaning and ■ Disposable syringe 20 ml subsection: ■ Place the product in a tray that is suitable for cleaning (avoiding rins- ■ Chapter Manual pre-cleaning with

■ FG849R ■ FG848R ■ FG851R ■ FG866R ■ FG868R Manual pre-cleaning with ultrasound and brush, and subsequent mechanical alkaline cleaning and thermal disinfection

■ FG861R ■ LX159R ■ LX185R

ing blind spots).

ing port of the injector carriage.

tion and subsection: ing and thermal disinfecting

■ Place products in the tray with their hinges open.

ing blind spots).

a brush

■ Connect components with lumens and channels directly to the rins- ■ Chapter Mechanical alkaline cleaning port of the injector carriage.

ing and thermal disinfecting

Chapter Mechanical cleaning/disinfec■ Suitable cleaning brush tion with manual pre-cleaning and ■ Disposable syringe 20 ml subsection: ■ Place the product in a tray that is suitable for cleaning (avoiding rins- ■ Chapter Manual pre-cleaning with ing blind spots).

ultrasound and brush

■ Connect components with lumens and channels directly to the rins- ■ Chapter Mechanical alkaline cleaning port of the injector carriage.

ing and thermal disinfecting

7

en 3.9

Manual cleaning/disinfection

► Prior to manual disinfecting, allow water to drip off for a sufficient

length of time to prevent dilution of the disinfecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for

residues. ► Repeat the cleaning/disinfection process if necessary.

3.9.1

Manual cleaning with immersion disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh

► Note the information on appropriate cleaning brushes and disposable

syringes, see Validated cleaning and disinfection procedure. Phase I ► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are moistened. ► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed from the surface. ► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe. Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least 5 times at the beginning of the exposure time

using an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. 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.

8

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure.

en 3.9.2

Manual cleaning with ultrasound and immersion disinfection

Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Ultrasonic cleaning

RT (cold)

>15

2

D–W

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

II

Intermediate rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

5

2

D–W

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

IV

Final rinse

RT (cold)

1

-

FD–W

-

V

Drying

RT

-

-

-

-

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) RT: Room temperature *Recommended: BBraun Stabimed fresh

► Note the information on appropriate cleaning brushes and disposable

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

ning water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing. ► Drain any remaining water fully. Phase III ► Fully immerse the product in the disinfectant solution. ► Mobilize non-rigid components, such as set screws, joints, etc. during

rinsing. ► Rinse lumens at least five times at the beginning of the exposure time

with an appropriate disposable syringe. Ensure that all accessible surfaces are moistened. Phase IV ► Rinse/flush the product thoroughly (all accessible surfaces) under run-

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

final rinse. ► Rinse lumens with an appropriate disposable syringe at least five times. ► Drain any remaining water fully.

Phase V ► Dry the product in the drying phase with suitable equipment (e.g. cloth,

compressed air), see Validated cleaning and disinfection procedure.

9

en 3.10 Mechanical cleaning/disinfection Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. 3.10.1 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

DW: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

10

en 3.11 Mechanical cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark according to DIN EN ISO 15883). Note The cleaning and disinfection device used for processing must be serviced and checked at regular intervals. 3.11.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Disinfecting cleaning

RT (cold)

>15

2

D–W

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

II

Rinsing

RT (cold)

1

-

D–W

-

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

► Note the information on appropriate cleaning brushes and disposable

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

syringes, see Validated cleaning and disinfection procedure.

cleaning. ► Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a disposable syringe.

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.

Phase II ► Rinse/flush the product thoroughly (all accessible surfaces) under running water. ► Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.

3.11.2 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.

11

en 3.11.3 Mechanical alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

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

■ 0.5 % working solution – pH = 11* III

Intermediate rinse

>10/50

1

FD-W

-

IV

Thermal disinfection

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning and disinfection device

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Check visible surfaces for residues after mechanical cleaning/disinfect-

ing.

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

3.12.1 Visual inspection ► Ensure that all soiling has been removed. In particular, pay attention to

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

12

3.12.2 Functional test CAUTION Damage (metal cold welding/friction corrosion) to the product caused by insufficient lubrication! ► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: STERILIT® I oil spray JG600 or STERILIT® I drip lubricator JG598). ► Assemble disassembled products, see Assembly. ► Check that the product functions correctly. ► Check that all moving parts are working property (e.g. hinges,

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

en 3.13 Assembly 3.13.1 Single drill guide FG868R ► Insert guide sleeve 1 by turning it counterclockwise. Be aware that it is a left-hand thread. You will hear and feel the guide sleeve clicking into position every half turn. 3.13.2 Depth gauge FG866R ► Slide knurled nut 7 over the tip of caliper 8. ► Place caliper 8 and knurled nut 7 assembly in outer shaft 6. ► Tighten knurled nut 7.

3.13.3 Screwdriver FG848R ► Slide the outer shaft 10 over the distal tip of the inner shaft. ► Tighten locking nut 9.

3.14 Packaging ► Appropriately protect products with fine working tips.

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.

► Place the product in its holder or on a suitable tray. Ensure that sharp

edges are covered. ► Package trays appropriately for the sterilization process (e.g. in

Aesculap sterile containers). ► Ensure that the packaging provides sufficient protection against con-

tamination of the product during storage.

3.15 Steam sterilization Note The product can be sterilized either in disassembled or in assembled condition. ► 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.

5.

Disposal

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

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

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

protected, dry, dark and temperature-controlled room.

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