Acculan 3Ti attachments

en

Aesculap® Acculan 3Ti Acculan 3Ti attachments Legend 1 Drill attachment (black unlocking sleeve) 2 Reamer attachment (blue unlocking sleeve) 2.1 Pull back unlocking sleeve 3 Drill attachment with Jacobs chuck 4 Kirschner wire attachment 4.1 Scale 4.2 Adjustment sleeve 4.3 Clamping lever 5 Drill attachment (for radiolucent angle transmission) 5.1 Adapter for radiolucent angle transmission 6 Adapter (AO large to DHS/DCS) 6.1 Pull back unlocking sleeve 7 Adapter (Hudson/Zimmer on Zimmer) 7.1 Unlocking sleeve 8 Sagittal saw attachment 8.1 Saw blade coupling 8.2 Button for saw blade release/fixation

Symbols on product and packages Caution Observe important safety information such as warnings and precautions in the instructions for use. Machine-readable, two-dimensional code The code contains a unique serial number which can be used for electronic tracking of the individual instrument. The serial number is based on the global standard sGTIN (GS1). Date of manufacture

SN

Manufacturer’s serial number

REF

Manufacturer’s article number Non-sterile medical product Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

Contents 1. 1.1 1.2 1.3 1.4 1.5 2. 3. 3.1 3.2 4. 4.1 4.2 4.2.1 4.2.2

LOT 2

Manufacturer’s batch designation

4.3 5. 5.1

General information... Intended use... Main functions and design characteristics Indications... Absolute contraindications... Relative contraindications... Safe handling... Product description... Scope of supply... Components required for operation... Drill and reamer attachments GB630R– GB638R / GB654R–GB658R... Operating principle... Safe operation... Coupling the tool/adapter to the drill and reamer attachments... Removing the tool/adapter from the drill and reamer attachments... Technical Data... Kirschner wire attachment GB643R... Operating principle...

4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 7 8 8

en 5.2 5.2.1 5.2.2 5.3 6.

Safe operation... 8 Inserting the Kirschner wire... 8 Clamping the Kirschner wire... 9 Technical Data... 9 Drill attachment GB645R (for radiolucent angle transmission)... 9 6.1 Operating principle... 9 6.2 Safe operation... 9 6.2.1 Coupling the radiolucent transmission unit 9 6.2.2 Uncoupling the radiolucent transmission unit... 9 6.2.3 Coupling a tool... 9 6.2.4 Uncoupling the tool... 9 6.3 Technical Data... 9 7. Adapter GB628R (AO large to DHS/DCS) . . . 10 7.1 Operating principle... 10 7.2 Safe operation... 10 7.2.1 Coupling the adapter... 10 7.2.2 Uncoupling the adapter... 10 7.2.3 Coupling a tool... 10 7.2.4 Uncoupling the tool... 10 7.3 Accessories... 10 7.4 Technical Data... 10 8. Adapter GB176R (Zimmer chuck with Hudson-Zimmer coupling)... 10 8.1 Operating principle... 10 8.2 Operation... 11 8.2.1 Coupling the adapter... 11 8.2.2 Uncoupling the adapter... 11 8.2.3 Coupling a tool... 11 8.2.4 Uncoupling the tool... 11 8.3 Technical Data... 11 9. Sagittal saw attachment GB660R... 11 9.1 Operating principle... 11 9.2 Safe operation... 11 9.2.1 Coupling the saw blade... 12 9.2.2 Uncoupling the saw blade... 12 9.3 Technical data... 12 10. Preparation... 12 11. Working with the attachments... 12 11.1 System set-up... 13 11.1.1 Connecting the accessories... 13 11.1.2 Coupling and uncoupling of attachments on the drill and reamer... 13 11.2 Function checks... 14 11.3 General operation... 14

12. 12.1 12.2 12.3 12.4 12.5 12.5.1

Validated reprocessing procedure... 15 General safety information... 15 General notes... 15 Preparation at the place of use... 16 Preparation before cleaning... 16 Cleaning/disinfection... 16 Product-specific safety instructions for the reprocessing procedure... 16 12.6 Manual cleaning with wipe disinfection . . 17 12.7 Automatic cleaning/disinfection with manual pre-cleaning... 18 12.7.1 Manual pre-cleaning with brush... 18 12.7.2 Mechanical alkaline cleaning and thermal disinfection... 19 12.8 Inspection, maintenance and checks... 20 12.9 Packaging... 20 12.10 Steam sterilization... 20 12.11 Storage... 20 13. Maintenance... 20 14. Troubleshooting list... 21 14.1 General malfunctions... 21 14.2 Malfunctions of the Kirschner wire attachment... 22 14.3 Malfunctions of the sagittal saw attachment22 15. Technical Service... 22 16. Accessories/Spare parts... 23 17. Technical Data... 24 17.1 Operating mode... 24 17.2 Ambient conditions... 25 18. Disposal... 25

3

en 1.

General information

1.1

Intended use

Task/Function The Acculan 3Ti small drill GA671 or drill and reamer GA672, combined with the relevant attachment and tool, is used for processing hard tissue, cartilage and the like, as well as bone replacement material, to screw bone pins in and out and to set transfixion wires. Application Environment The product is used in operating rooms in sterile zones outside of the explosion risk zone (such as areas with pure oxygen or anesthesia gases).

1.2

Main functions and design characteristics

Speed

GB628R GB654R GB655R GB656R GB658R

0 min-1 to max.

GB645R

0 min-1 to max.

250 min-1

Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) Drilling (clockwise/counterclockwise rotation): ■ 60 second application, 60 second pause

■ 20 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Reaming (clockwise/counterclockwise rotation): ■ 30 second application, 30 second pause

■ 8 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Drilling (oscillation):

■ 60 second application, 60 second pause 900 min-1

GB176R GB630R GB634R GB635R GB636R GB637R GB638R GB643R

0 min-1 to max.

Oscillation frequency

GB660R

0 min-1 to max.

Rotational direction

Right and left rotation, oscillation

4

Operating mode

1 000 min-1

■ 4 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C Saw mode with GB660R:

■ 30 second application, 60 second pause

■ 3 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C 17 000 min-1

en 1.3

Indications

The type and area of application depend on the tool selected.

1.4

Absolute contraindications

The product is not licensed for use on the central nervous system or central circulatory system.

1.5

Relative contraindications

The safe and effective use of the product greatly depends on influences which can only be controlled by the user. Therefore the specifications provided represent framework conditions only. Clinically successful use of the product is dependent on the knowledge and experience of the surgeon. The surgeon must decide which structures it is sensible to treat and take into account the safety and warning information contained in these instructions for use.

2.

► Ensure that the product and its accessories are

operated and used only by persons with the requisite training, knowledge, or experience. ► Use product and accessories in surgery and/or in the framework of emergency medical care. ► Keep the instructions for use accessible for the user. ► Always adhere to applicable standards.

3.

Product description

3.1

Scope of supply

Designation

Art. no.

Enclosed

Key for Jacobs chuck attachments

GA031201

For drill attachment GB634R, GB638R and reamer attachment GB658R

Safe handling

WARNING

WARNING

Risk of injury and material damage if this product is not used as intended! ► Use the product only for its intended purpose. Risk of injury and damage to property due to improper handling of the product! ► Follow the instructions for use of all products used.

► Remove the transport packaging and clean the new

product, either manually or mechanically, prior to its initial sterilization. ► Prior to use, check that the product is in good working order. ► To prevent damage caused by improper setup or operation, and in order not to compromise warranty and manufacturer liability: – Use the product only according to these instructions for use. – Follow the safety and maintenance instructions. – Only combine Aesculap products with each other.

3.2

Components required for operation

Art. no.

Designation

GA671

Acculan 3Ti small drill

GA672

Acculan 3Ti drill and reamer

Vary with indication

Attachment

Vary with indication

Adapter

Vary with indication

Appropriate tools and Kirschner wires

Note For possible combinations of attachments with the Acculan 3Ti small power drill GA671, follow the information in Instructions for Use, see TA012033!

5

en 4.

Drill and reamer attachments GB630R–GB638R / GB654R–GB658R

Note The keyless GB634R Jacobs chuck may open during lefthand rotation of tools (e.g. when pulling out tools). To operate tools in left-hand rotation, use the Jacobs chuck with key GB638R.

4.2.1

Coupling the tool/adapter to the drill and reamer attachments

► Slide back unlocking sleeve 2.1. ► Insert the tool/adapter shaft in its correct position

Fig. 1

4.1

Operating principle

The drill and reamer attachments are powered by a motor coupled through an Aesculap Acculan 3Ti coupling. The drill and reamer attachments convert the motor rotation to rotation of the tool adapted in the respective attachment. The drill and reamer attachments can be coupled to the drive unit in three different angular positions at steps of 120°. Drill attachments are identified by their black unlocking sleeves, whereas reamer attachments come with blue unlocking sleeves.

4.2

Safe operation

DANGER

Risk of injury by heat necrosis! ► Do not use drill attachments to operate reamer tools such as the acetabulum reamer and the medullary reamer. ► Operate any reamer tool only with a reamer attachment.

Recommended application Use GB630R, GB634R, GB635R, GB636R, GB637R and GB638R only for drilling and reaming. Use GB654R, GB655R, GB656R and GB658R only for reaming and intramedullary drilling. ► For information on how to connect the drill and reamer attachments, see Chapter 11.1.2.

6

down to the stop in the tool coupling of the attachment. ► Release unlocking sleeve 2.1. The tool/adapter is now coupled.

4.2.2

Removing the tool/adapter from the drill and reamer attachments

► Slide back unlocking sleeve 2.1. ► Remove the tool/adapter.

en 4.3

Technical Data

Drill attachments (black unlocking sleeve) GB630R

GB634R

GB635R

GB636R

GB637R

GB638R

Connector

Hudson/Zimmer

Jacobs chuck keyless ∅ 0.3 mm to 7.4 mm

AO small

Aesculap Hexagon

Trinkle

Jacobs chuck with key ∅ 0.5 mm to 7.4 mm

Size Length x ∅ in mm

approx. 100 x 39

approx. 125 x 39

approx. 90 x 39

approx. 86 x 39

approx. 93 x 39

approx. 110 x 39

Weight, in grams

approx. 263

approx. 430

approx. 246

approx. 253

approx. 250

approx. 333

Gear ratio

25:1

25:1

25:1

25:1

25:1

25:1

Drive speed, in 1/min

max. 1 000

max. 1 000

max. 1 000

max. 1 000

max. 1 000

max. 1 000

Torque, in Nm

max. 5

max. 5

max. 5

max. 5

max. 5

max. 5

Cannulation in mm

4

4

4

4

4

4

Reamer attachments (blue unlocking sleeve) GB654R

GB655R

GB656R

GB658R

Connector

Harris

AO large

Hudson/Zimmer

Jacobs chuck with key ∅ 0.5 mm to 7.4 mm

Size Length x ∅ in mm

approx. 106 x 39

approx. 107 x 39

approx. 118 x 39

approx. 133 x 39

Weight, in grams

approx. 323

approx. 334

approx. 344

approx. 415

Gear ratio

100:1

100:1

100:1

100:1

Drive speed, in 1/min

max. 250

max. 250

max. 250

max. 250

Torque, in Nm

max. 19

max. 19

max. 19

max. 19

Cannulation ∅ in mm

4

4

4

4

7

en 5.

Kirschner wire attachment GB643R

5.2

Safe operation

To protect against injuries when using long drilling wires, screw in the Kirschner wire protection sleeve supplied with the product. ► Screw Kirschner wire protection sleeve 15 into adapter 17, see Fig. 3.

17

15

Fig. 2

5.1

Operating principle

Kirschner wire attachments are powered by a motor with an Aesculap Acculan 3Ti coupling. The Kirschner wire attachment is a quick-action chuck that clamps and drives Kirschner wires.

Fig. 3 ► Connect the Kirschner wire attachment, see

Chapter 11.1.2. ► Align clamping lever 4.3 over the trigger buttons of

the drill and reamer.

5.2.1

Inserting the Kirschner wire

The following diameter ranges can be set for the adjustment sleeve: ■ 0.6 mm to 1.8 mm ■ 1.8 mm to 3.0 mm ■ 3.0 mm to 4.0 mm ► Leave clamping lever 4.3 in forward position (away from the drive unit). ► Set adjustment sleeve 4.2 to the correct diameter range for the diameter of the Kirschner wire: Push back and turn adjustment sleeve 4.2 until the intended diameter range setting is reached. ► Release adjustment sleeve 4.2, making certain that adjustment sleeve 4.2 clicks into position. ► Insert the Kirschner wire into the Kirschner wire attachment until the required extension length is reached. The Kirschner wire is held in the intended position in the attachment by an automatic clamping mechanism. 8

en 5.2.2 Clamping the Kirschner wire

6.1

► Pull clamping lever 4.3 towards the motor unit (the

The drill attachment is powered by a motor unit with the Aesculap Acculan 3Ti coupling. The drill attachment transfers the rotational speed of the motor to the adapted radiolucent angle transmission. The drill attachment can be coupled to the motor unit in three different positions, separated by 120°.

stronger the clamping lever is pulled, the stronger the clamping force on the Kirschner wire). The Kirschner wire is clamped in now. Note The Kirschner wire remains clamped only as long as the clamping lever is pulled towards the motor unit. The clamping lever automatically returns to its rest position away from the motor unit, and the Kirschner wire can be moved freely again as soon as the clamping lever is released.

5.3

Technical Data

6.2

Operating principle

Safe operation

► Couple the drill attachment, see Chapter 11.1.2.

6.2.1

Coupling the radiolucent transmission unit

► Fully engage the radiolucent angle transmission in

adapter 5.1 of the drill attachment.

GB643R

► If necessary, slightly move the radiolucent unit.

Kirschner wire ∅ in mm

0,6–4,0

6.2.2

Dimensions L x W x H, in mm

93 x 36 x 137

Weight, in grams

approx. 300

Gear ratio

25:1

6.2.3

max. 1 000

Note Always observe the instructions for use of Synthes Radiolucent Drive 511.300!

Drive speed, in 1/min

6.

Uncoupling the radiolucent transmission unit

► Forcefully pull out the radiolucent angle transmis-

Drill attachment GB645R (for radiolucent angle transmission)

sion from the drill attachment.

6.2.4

Coupling a tool

Uncoupling the tool

Note Always observe the instructions for use of Synthes Radiolucent Drive 511.300!

6.3

Technical Data GB645R

Fig. 4

Dimensions L x W x H, in mm

110 x 35 x 35

Note The drill attachment can be used only with Synthes Radiolucent Drive 511.300!

Weight, in grams

approx. 225

Gear ratio

30:1

Drive speed, in 1/min

max. 900

Note Always observe the instructions for use of Synthes Radiolucent Drive 511.300!

9

en 7.

Adapter GB628R (AO large to DHS/DCS)

Fig. 5

7.1

Accessories

Designation

Synthes Art. no.

DHS Tripple Reamer

338.130, 338.430

DHS Reamer

357.044, 357.045

DHS Drill Bit

357.047, 351.270, 359.081, 359.079

7.4

Technical Data

Operating principle

The adapter couples a tool to the DHS/DCS shaft and enables an Acculan 3Ti motor to be connected

7.2

7.3

Safe operation

Note The adapter is only suitable for use with Synthes tools with DHS/DCS tool coupling or tools of a comparable geometry! ► For information on how to connect the drill and

GB628R Dimensions L x W x H, in mm

61 x 22 x 22

Weight, in grams

approx. 70

Drive speed, in 1/min

max. 250

8.

reamer attachments, see Chapter 11.1.2.

7.2.1 Coupling the adapter

Adapter GB176R (Zimmer chuck with Hudson-Zimmer coupling)

► For coupling the adapter, see Chapter 4.2.1.

7.2.2 Uncoupling the adapter ► For uncoupling the adapter, see Chapter 4.2.2.

7.2.3 Coupling a tool ► Slide back unlocking sleeve 6.1. ► Insert the tool shaft in its correct position down to

the stop in the tool coupling of the adapter. ► Release unlocking sleeve 6.1.

The tool is now coupled.

7.2.4 Uncoupling the tool ► Slide back unlocking sleeve 6.1. ► Remove the tool.

10

Fig. 6

8.1

Operating principle

The adapter couples a tool to the Zimmer tool shaft and enables an Acculan 3Ti motor to be connected. Note The adapter is only suitable for use with drill/reamer attachments with a series number of “SN 500" and above!

en 8.2

9.

Operation

Sagittal saw attachment GB660R

Note The Zimmer-Hudson adapter is only suitable for use with Zimmer tools and tools with a comparable geometry! ► For information on how to connect the drill and

reamer attachments, see Chapter 11.1.2.

8.2.1 Coupling the adapter ► For coupling the adapter, see Chapter 4.2.1.

8.2.2 Uncoupling the adapter ► For uncoupling the adapter, see Chapter 4.2.2.

8.2.3 Coupling a tool ► Push unlocking sleeve 7.1 forward and hold. ► Insert the tool shaft in its correct position down to

the stop in the tool coupling of the adapter. ► Release unlocking sleeve 7.1.

The tool is now coupled.

8.2.4 Uncoupling the tool ► Push unlocking sleeve 7.1 forward and hold. ► Remove the tool.

8.3

Fig. 7

9.1

9.2

Technical Data

Operating principle

The sagittal saw attachment is powered by a motor unit with the Aesculap Acculan 3Ti coupling. The sagittal saw attachment converts the motor rotation into oscillation of the saw blade. The bone is dissected by the oscillating movement of the saw blade. No key or wrench is required for inserting the saw blades. The sagittal saw attachment can be coupled to the drive unit in three different positions separated by steps of 120°.

Safe operation

GB176R Dimensions L x W x H, in mm

50 x 22 x 22

Weight, in grams

approx. 55

Drive speed in 1/min (GB656R)

max. 250

Drive speed in 1/min (GB630R)

max. 1 000

WARNING

Risk of injury caused by inadvertent loosening of the saw blade during operation! ► Do not press the button for saw blade release/fixation during operation. ► Check for secure fixation of the tool after any tool change.

► Connect

the sagittal saw attachment, see Chapter 11.1.2.

11

en 9.2.1 Coupling the saw blade ► Insert the saw blade with its coupling end in the

slot of saw blade coupling 8.1 as far as it will go. Ensure that the locking pin engages in the saw blade fenestration, and that the lateral stops of the saw blade rest on the coupling. ► If necessary press button for saw blade release/fixation 8.2. ► Check that the tool is seated properly: Pull at the saw blade.

11.

Working with the attachments

WARNING

Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use pursuant to the operating instructions.

9.2.2 Uncoupling the saw blade ► Fully press down the button for saw blade

release/fixation 8.2. ► Extract the saw blade from saw blade coupling 8.1.

9.3

WARNING

Technical data GB660R

Dimensions L x W x H, in mm

89 x 36 x 44

Weight, in grams

approx. 270

Gear ratio

1.5:1

Stroke frequency in 1/min

max. 17 000

Saw blades max. working length in mm

50

WARNING

Risk of injury and material damage due to inappropriate use of tools! ► Always follow the safety advice and information given in the instructions for use. ► When coupling/uncoupling, handle tools with cutting edges with care. Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check.

10. Preparation Non-compliance with the following instructions will preclude all responsibility and liability in this respect on the part of Aesculap.

12

WARNING

Risk of burns to skin and tissue through blunt tools or if product has not been maintained properly! ► Use tools only if they are in perfect condition. ► Replace blunt tools. ► Maintain the product properly, see maintenance guide.

en 11.1 System set-up

CAUTION

Damage to the attachment caused by inappropriate tool! ► Use an appropriate tool for changing the attachment tool. Avoid contact with cutting edges.

11.1.2 Coupling and uncoupling of attachments on the drill and reamer Protection against inadvertent activation

11.1.1 Connecting the accessories

DANGER

Risk of injury due to unapproved configuration using additional components! ► For all applied components, ensure that their classification matches that of the application component (e.g. Type BF or Type CF) of the respective device.

Combinations of accessories that are not mentioned in the present instructions for use may only be employed if they are specifically intended for the respective application, and if they do not compromise the performance and safety characteristics of the products. ► Please address your B. Braun/Aesculap partner or Aesculap Technical Service with any inquiries in this respect; for a contact address, see Chapter 15.

Fig. 8 The rotational speed control button can be locked to prevent inadvertent activation of the drill and reamer during a tool change. Note For further information on the drill and reamer, see TA011869. Coupling ► Push the attachment onto drill and reamer A until it engages with a click, see Fig. 9.

A Fig. 9 Uncoupling ► Turn rotating sleeve B in the direction of the arrow (clockwise when viewed from the rear end of drill 13

en and reamer A), see Fig. 10.

11.3 General operation

B WARNING

A Fig. 10 ► Remove the attachment from drill and reamer A.

11.2 Function checks Note Function checks must be performed prior to each operation with the unit and after each intraoperative attachment or tool change! ► Check to ensure that the attachment/adapter is

securely coupled by pulling. ► Make certain that the tool/Kirschner wire is seated

properly. ► Briefly run the drill and reamer, with the attachment coupled and a tool inserted, at maximum speed in clockwise and counterclockwise mode. ► Watch out for damage, irregular running noises, excessive vibrations and excessive heat developed by the handpieces. ► Only use the unit if it is in perfect condition.

WARNING

WARNING

WARNING

14

Coagulation of patient tissue or risk of burns for patients and user through hot product! ► Do not use drill attachments to operate reamer tools such as the acetabulum reamer and the medullary reamer. ► Operate any reamer tool only with a reamer attachment. ► Cool the tool during operation. ► Keep product/tool out of the reach of patients. ► Let the product/tool cool down. ► Use a cloth to protect against burns when changing the tool. Risk of infection or injury through aerosol formation or particles ejected from the tool! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction). Risk of injury and/or malfunction! ► Always carry out a function test prior to each use of the product. Risk of injury when attaching/removing attachments/tools in the ON position through inadvertent activation of the product! ► Only attach/remove attachments/tools in the OFF position.

en

WARNING

WARNING

Risk of injury due to application of the product outside the field of view! ► Only use the product under vision. Risk of injury and damage to the tool/system! The rotating tool may get caught in drapes (such as textiles). ► Do not let the tool come into contact with drapes (such as textiles) during operation.

► Start the motor powering the attachment at mod-

erate speed. ► To avoid slipping, apply only moderate pressure. ► To avoid tool breakage, do not bend the tool. ► Cool the tool during operation. This will improve

chip removal and reduce the risk of necrosis.

12. Validated reprocessing procedure 12.1 General safety information Note Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for reprocessing. 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 It should be noted that successful reprocessing of this medical device can only be guaranteed following prior validation of the reprocessing method. The operator/reprocessor is responsible for this. The recommended chemical 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 https://extranet.bbraun.com The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

12.2 General notes Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore, no more than 6 hours should be left between use and preparation, pre-clean temperatures >45 °C liable to fusing should not be employed and disinfectants liable to fusing (aldehyde or alcohol-based) should not be used. Excessive neutralizing agents or basic cleaners may result in a chemical attack and/or fading and the laser marking becoming unreadable either visually or by machine in case of non stainless steel. On stainless steel, residues containing chlorine or chloride (such as surgical residues, drugs, saline solutions in water for cleaning, disinfection and sterilization) may lead to corrosion (pitting corrosion, tensile corrosion) and thus to the destruction of the product. These must be removed by rinsing thoroughly with demineralized water and then drying. Perform additional drying, if necessary.

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

15

en 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 reprocessing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems: ■ Visual material changes (such as fading or color changes in titanium or aluminum). For aluminum, the application/process solution only needs to be pH >8 to cause visible surface changes. ■ Material damage (such as corrosion, cracks, breaks, premature aging or swelling). ► Do not use metal cleaning brushes or other abrasives that would damage the product surface and could cause corrosion. ► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.a-k-i.org, section Publications, Red Brochure – Proper maintenance of instruments.

12.3 Preparation at the place of use ► Remove all attached components from the product

(tool and accessories). ► Remove the attachment from drill and reamer. ► Remove any visible surgical residues as much as

possible with a damp, lint-free cloth. ► Place the dry product in a sealed waste container

and forward it on for cleaning and disinfection within 6 hours.

12.4 Preparation before cleaning ► Before the first automatic cleaning/disinfection:

attach ECCOS fixations in a suitable sieve basket.

12.5 Cleaning/disinfection 12.5.1 Product-specific safety instructions for 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 – be approved for plastic material and highgrade steel, – do not attack softeners (e.g. in silicone). ► Do not use cleaning agents that contain acetone. ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C during chemical cleaning and/or disinfection. ► Do not exceed the maximum temperature of 96 °C during thermal disinfection with FD water. ► Dry the product for at least 10 minutes at a maximum of 120 °C.

► Insert the product in its proper position in the

ECCOS fixations. Kirschner wire attachment GB643R ► Turn adjustment sleeve 4.2 to setting for largest

Kirschner wire diameter.

16

Note The indicated drying time is a guide time only. It must be checked taking into account the specific conditions (e.g. load) and if applicable adjusted.

en 12.6 Manual cleaning with wipe disinfection Phase

Step

D [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry

I

Pre-cleaning

RT (cold)

≥2

-

D–W

until visually clean

II

Cleaning with enzyme solution

RT (cold)

≥2

0.8

D–W

pH-neutral*

III

Intermediate rinse

RT

≥5

-

DW

–

IV

Drying

RT

-

-

-

-

V

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

VI

Final rinse

RT (cold)

0.5

-

FD–W

-

VII

Drying

RT

-

-

-

-

D–W: FD–W: RT: *

Drinking water Fully desalinated water (demineralized, microbiological, at least of drinking water quality) Room temperature validated with enzyme cleaner “Cidezyme Johnson & Johnson”

► Do not clean the product in a ultrasonic bath and

do not immerse the product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Mobilize non-rigid components during cleaning. ► Clean the product under running water, using a

suitable cleaning brush until all visible residues have been removed from the surfaces. ► Brush cannulation with cleaning brush TA011944 and difficult to access surfaces with a suitable cleaning brush made of plastic for at least 1 min. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com). Phase II ► Follow the operating instructions of the enzyme cleaner with regard to correct concentration, dilution, temperature and water quality. ► Spray products with a pH neutral enzyme solution, let soak in for at least 2 minutes and then wipe off.

Phase III ► Mobilize non-rigid components during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► Follow the operating instructions of the enzyme cleaner with regard to correct concentration, dilution, temperature and water quality. ► Contamination should be removed with a lint-free cloth or soft brush moistened with enzyme cleaner. ► Flexible components (such as sleeves) and cannulations should be rinsed for 20 seconds with the water pistol (cold water, at least 2.5 bar). ► After manual cleaning, check visible surfaces and areas of flexible components for residues. ► If necessary, repeat the cleaning process (phase 1 to 3). Phase IV ► Dry the product in the drying phase with suitable equipment (such as lint-free cloths, pressurized air). Phase V ► Wipe all surfaces of the product with a single-use disinfecting wipe.

17

en Stage VI ► Rinse disinfected surfaces after the prescribed reaction time for at least 1 minute under running demineralized water. ► Drain any remaining water fully.

Stage VII ► Dry the product in the drying phase with suitable equipment (such as lint-free cloths, pressurized air).

12.7 Automatic cleaning/disinfection with manual pre-cleaning Note The cleaning and disinfection device must fundamentally have a tested efficacy (such as FDA approval or CE label pursuant to DIN EN ISO 15883).

Note The washer-disinfector machine used for processing must be serviced and checked at regular intervals.

12.7.1 Manual pre-cleaning with brush Phase

Step

D [°C/°F]

I

Rinsing

II

Brushes

D–W: RT:

t [min]

Conc. [%]

Water quality

Chemistry/Note

RT (cold) -

-

D–W

until visually clean

RT (cold) -

-

D–W

until visually clean

Drinking water Room temperature

► Do not clean the product in a ultrasonic bath and

do not immerse the product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. ► For Kirschner wire attachment GB643R: set the adjustment sleeve 4.2 to the greatest Kirschner wire diameter. Phase I ► Mobilize non-rigid components during cleaning. ► Thoroughly clean the product under running water.

Phase II ► Mobilize non-rigid components during cleaning. ► Brush cannulation with cleaning brush TA011944

and difficult to access surfaces with a suitable cleaning brush made of plastic for at least 1 min. ► After manual preparation, check visible surfaces for residue and repeat the pre-cleaning process as needed. Note For details on difficult to access surfaces, see Acculan pre-cleaning and care information TA016000 (available in Aesculap Extranet at https://extranet.bbraun.com).

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en 12.7.2 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfecting machine without ultrasound Phase

Step

D [°C/°F]

t [min]

Water quality

Chemistry/Note

I

Pre-rinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD–W

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

■ working solution 0.5 % – pH ~ 11* III

Intermediate rinse

> 10/50

1

FD–W

-

IV

Thermal disinfection

90/194

5

FD–W

-

V

Drying

-

-

-

mind. 10 min at max. 120 °C

D–W: Drinking water FD–W: Fully desalinated water (demineralized, microbiological, at least of drinking water quality) *Recommended: BBraun Helimatic Cleaner alcaline ► For Kirschner wire attachment GB643R: set the

adjustment sleeve 4.2 to the greatest Kirschner wire diameter. ► Insert the product in its proper position in the ECCOS fixation. ► Then connect the interior rinse device to the ECCOS fixation and connect to the rinse connector of the cleaning/disinfection device/rinse cart. ► After automatic cleaning/disinfection, check visible surfaces for residues and repeat the cleaning/disinfection process as needed.

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en 12.8 Inspection, maintenance and checks ► Allow the product to cool down to room tempera-

ture. ► Inspect the product after each cleaning and disin-

fecting cycle to be sure it is: clean, functional, and undamaged. ► Spray product after every cleaning and disinfection with Acculan 4 oil spray adapter GB600840 (black) for approx. 2 sec. with Aesculap STERILIT Power Systems oil spray GB600; see Fig. 11.

► Pack trays appropriately for the sterilization pro-

cess (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontam-

ination of the product.

12.10 Steam sterilization Note Remove all attached components from the product (tools, accessories) before sterilization. ► 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). ► Use a validated sterilization method: – Steam sterilization using fractional vacuum process – Steam sterilizer DIN EN 285 and validated pursuant to DIN EN ISO 17665 – Sterilization using fractionated vacuum process at 134 °C/holding time 5 min When sterilizing multiple products in one steam sterilizer: ► Ensure that the maximum permitted load specified by the manufacturer for the steam sterilizer is not exceeded.

12.11 Storage ► Store sterile products in germ-proof packaging,

Fig. 11 Note Aesculap additionally recommends occasional spraying of moving parts (such as knobs, couplings, cover lids) with the Aesculap STERILIT-Power-Systems oil spray. ► Check the product for any damage, abnormal run-

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

13.

Maintenance

To ensure reliable operation, the product must be maintained as indicated on the maintenance label once per year, see Fig. 12, e.g. in February 2012.

ning noise, overheating or excessive vibration. ► Set aside the product if it is damaged.

12.9 Packaging ► Always follow the instructions for use of the

respective packaging and storage devices (e.g. instructions for use TA009721 for Aesculap-ECCOS fixation system). ► Insert the product in its proper position in the ECCOS fixations.

20

Fig. 12 For technical service, please contact your national B. Braun/Aesculap agency, see Chapter 15.