Revision V6

Page 2

Note

If there is no final sterilization, then a virucidal disinfectant must be used.

Aesculap®

Modular instrument system

Note

For the latest information on reprocessing and material compatibility see also the Aesculap extranet at

www.extranet.bbraun.com

The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

Legend

General information

1

2

3

4

5

Available sizes

Dried or affixed surgical residues can make cleaning more difficult or ineffective and lead to corrosion. Therefore the

time interval between application and processing should not exceed 6 h; also, neither fixating pre-cleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should be used.

Excessive measures of neutralizing agents or basic cleaners may result in a chemical attack and/or to fading and the

laser marking becoming unreadable visually or by machine for stainless steel.

Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water

used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in

the destruction of stainless steel products. These must be removed by rinsing thoroughly with demineralized water

and then drying.

Additional drying, if necessary.

Only process chemicals that have been tested and approved (e.g. VAH or FDA approval or CE mark) and which are

compatible with the product’s materials according to the chemical manufacturers’ recommendations may be used

for processing the product. All the chemical manufacturer's application specifications must be strictly observed. Failure to do so can result in the following problems:

■ Optical changes of materials, e.g. fading or discoloration of titanium or aluminum. For aluminum, the application/process solution only needs to be of pH >8 to cause visible surface changes.

■ Material damage such as corrosion, cracks, fracturing, premature aging or swelling.

► Do not use metal cleaning brushes or other abrasives that would damage the product surfaces and could cause

corrosion.

► Further detailed advice on hygienically safe and material-/value-preserving reprocessing can be found at www.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

■

■

Preparations at the place of use

Handle: fixed handle part

Handle: movable handle part

Shaft

Work length marking

Handle

Symbols on product and packages

Caution, general warning symbol

Caution, see documentation supplied with the product

Intended use

The modular instrument system is used for microsurgical procedures in neurosurgery and in other surgical disciplines.

Different handle diameter

Shafts with different working ends

Note

Detailed information about the available models and sizes is given in the Aesculap brochures.

Safe handling and preparation

CAUTION

Federal law restricts this device to sale by, or on order of a physician!

► Ensure that the product and its accessories are operated and used only by persons with the requisite training,

knowledge, or experience.

► Read, follow, and keep the instructions for use.

► Use the product only in accordance with its intended use, see Intended use.

► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial

sterilization.

► Store any new or unused products in a dry, clean, and safe place.

► Prior to each use, inspect the product for loose, bent, broken, cracked, worn, or fractured components.

► Do not use the product if it is damaged or defective. Set aside the product if it is damaged.

► Replace any damaged components immediately with original spare parts.

► To avoid damage to the working end: Carefully insert the product through the working channel (e.g. trocar).

Safe operation

WARNING

► If applicable, rinse non-visible surfaces preferably with deionized water, with a disposable syringe for example.

► Remove any visible surgical residues to the extent possible with a damp, lint-free cloth.

► Transport the dry product in a sealed waste container for cleaning and disinfection within 6 hours.

Preparation before cleaning

► Dismantle the product prior to cleaning, see Disassembling.

Cleaning/disinfection

Product-specific safety notes on the reprocessing procedure

CAUTION

Damage to the product due to inappropriate cleaning/disinfecting agents and/or

excessive temperatures!

► Use cleaning and disinfecting agents approved for, e.g., aluminum, plastics and

high-grade steel, according to the manufacturer’s instructions.

► Observe specifications regarding concentration, temperature and exposure

time.

► Do not exceed the maximum allowable temperature of 60 °C.

► Do not use oxidizing chemicals (e.g. H2O2), which could cause bleaching/layer loss of the product.

► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam forma-

Risk of injury and/or malfunction!

► Always carry out a function check prior to using the product.

► Ensure that the clamped shaft is locked and fixed.

► Pay attention to the pointed and sharp working ends of the shaft.

► Pay attention to the “min” and “max” markings on the shaft. The shaft can

move in an uncontrolled way outside the area.

► Open handle 5 (if necessary).

► Insert the shaft 3 into the handle 5, see Fig. 1.

► If the shaft 3 cannot be inserted into the handle 5: Slightly unscrew fixed handle part 1 and movable handle

part 2 from one another.

► Set the working length in accordance with the working length marking 4, see Fig. 2.

► Lock the shaft 3 in place. To this end, screw the movable handle part 2 onto the fixed handle part 1 until you

feel resistance, see Fig. 4.

Disassembling

► Slightly unscrew fixed handle part 1 and movable handle part 2 from one another.

► Pull the shaft 3 out of the handle 5 in a forwards direction, see Fig. 1.

► Entirely unscrew fixed handle part 1 and movable handle part 2 from one another, see Fig. 3.

tion and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the

product thoroughly with running water.

► Clean and disinfect microsurgical products mechanically if they can be placed securely in the machine or on the

positioning aids.

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion

disinfection

■

■

■

Chapter Manual cleaning/disinfection and sub-chapter:

Manual pre-cleaning with brush

and subsequent mechanical alkaline cleaning and thermal disinfection

■

■

■

■

Assembling

► Screw together the fixed handle part 1 and movable handle part 2 almost all the way, see Fig. 3.

► Insert the shaft 3 into the handle 5, see Fig. 1.

► If the shaft 3 cannot be inserted into the handle 5: Slightly unscrew fixed handle part 1 and movable handle

part 2 from one another.

► Set the working length in accordance with the working length marking 4, see Fig. 2.

► Lock the shaft 3 in place. To this end, screw the movable handle part 2 onto the fixed handle part 1 until you

feel resistance, see Fig. 4.

Cleaning brush: e.g. TA011204

20 ml disposable syringe

Drying phase: Use a lint-free

cloth or medical compressed air

Cleaning brush: e.g. TA011204

20 ml disposable syringe

Place the product in a tray that

is suitable for cleaning (avoiding rinsing blind spots).

Place products in the tray with

their hinges open.

■

Chapter Manual cleaning with

immersion disinfection

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and sub-chapter:

■

■

Chapter Manual pre-cleaning

with a 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 dis-

infecting solution.

► After manual cleaning/disinfection, check visible surfaces visually for residues.

► Repeat the cleaning /disinfection process if necessary.

Manual cleaning with immersion disinfection

Validated reprocessing procedure

General safety instructions

Note

Adhere to national statutory regulations, national and international standards and directives, and local, clinical

hygiene instructions for sterile processing.

Note

For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant

national regulations concerning the reprocessing of products.

Phase

Step

T

[°C/°F]

t

[min]

Conc.

[%]

Water

quality

Chemical

I

Disinfecting

cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free,

and QUAT-free concentrate,

pH ~ 9*

II

Intermediate

rinse

RT (cold)

1

-

D–W

-

III

Disinfection

RT (cold)

15

2

D–W

Aldehyde-free, phenol-free,

and QUAT-free concentrate,

pH ~ 9*

IV

Final rinse

RT (cold)

1

-

FD-W

-

V

Drying

RT

-

-

-

-

Note

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

Note

Successful processing of this medical device can only be ensured if the processing method is first validated. The operator/sterile processing technician is responsible for this.

The recommended chemistry was used for validation.

Page 3

D–W:

FD–W:

Drinking water

Fully desalinated water (demineralized, low microbiological contamination: drinking water quality

at least)

RT:

Room temperature

*Recommended: BBraun Stabimed

► Check visible surfaces for residues after mechanical cleaning/disinfecting.

Inspection, maintenance and checks

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure.

CAUTION

Phase I

► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are

moistened.

► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed

from the surface.

► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

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

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

disposable syringe.

Phase II

► Rinse/flush the product thoroughly (all accessible surfaces) under running water.

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

► Drain any remaining water fully.

Damage (metal seizure/friction corrosion) to the product caused by insufficient

lubrication!

► Prior to function checks, lubricate moving parts (e.g. joints, pusher components and threaded rods) with maintenance oil suitable for the respective sterilization process (e.g. for steam sterilization: Aesculap STERILIT® I oil spray

JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature.

► After each complete cleaning, disinfecting and drying cycle, check that the product is dry, clean, operational, and

free of damage (e.g. broken insulation or corroded, loose, bent, broken, cracked, worn, or fractured components).

Dry the product if it is wet or damp.

Repeat cleaning and disinfection of products that still show impurities or contamination.

Check that the product functions correctly.

Immediately put aside damaged or inoperative products and send them to Aesculap Technical Service, see Technical Service.

► Check for compatibility with associated products.

►

►

►

►

Packaging

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.

►

►

►

►

Appropriately protect products with fine working tips.

Place the product in its holder or on a suitable tray. Ensure that all cutting edges are protected.

Pack trays appropriately for the intended sterilization process (e.g. in Aesculap sterile containers).

Ensure that the packaging provides sufficient protection against recontamination of the product during storage.

Steam sterilization

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.

Note

The product may only be sterilized when dismantled.

► 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).

Phase V

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

and disinfection procedure.

Mechanical cleaning/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.

► Validated sterilization process

– Disassemble the product

– Steam sterilization through fractionated vacuum process

– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665

– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min

► When sterilizing several products at the same time in a steam sterilizer, ensure that the maximum load capacity

of the steam sterilizer specified by the manufacturer is not exceeded.

Sterilization for the US market

■ Aesculap advises against sterilizing the device by flash sterilization or chemical sterilization.

■ Sterilization may be accomplished by a standard prevacuum cycle in a steam autoclave.

To achieve a sterility assurance level of 10-6 , Aesculap recommends the following parameters:

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*

Rinsing

RT (cold)

II

1

-

D–W

-

D–W:

Drinking water

RT:

Room temperature

*Recommended: BBraun Stabimed

► Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-

infection procedure.

Phase I

► Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are

moistened.

► Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed

from the surface.

► If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.

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

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

disposable syringe.

Phase II

► Rinse/flush the product thoroughly (all accessible surfaces) under running water.

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

Aesculap Orga Tray/Sterile container (perforated bottom)

Minimum cycle parameters*

Sterilization method

Temp.

Time

Minimum drying time

Prevacuum

270 °F/275 °F

4 min

20 min

*Aesculap has validated the above sterilization cycle and has the data on file. The validation was accomplished in an

Aesculap sterile container cleared by FDA for the sterilization and storage of these products. Other sterilization cycles

may also be suitable, however individuals or hospitals not using the recommended method are advised to validate

any alternative method using appropriate laboratory techniques. Use an FDA cleared accessory to maintain sterility

after processing, such as a wrap, pouch, etc.

WARNING for the US market

If this device is/was used in a patient with, or suspected of having Creutzfeldt-Jakob Disease (CJD), the device

cannot be reused and must be destroyed due to the inability to reprocess or sterilize to eliminate the risk of

crosscontamination.

Storage

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

Technical Service

Risk of injury and/or malfunction!

► Do not modify the product.

WARNING

► For service and repairs, please contact your national B. Braun/Aesculap agency.

Mechanical alkaline cleaning and thermal disinfecting

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

Phase

Step

T

[°C/°F]

t

[min]

Water

quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■

■

Concentrate, alkaline:

– pH = 13

– <5 % anionic surfactant

0.5 % working solution

– pH = 11*

III

Intermediate

rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

V

Drying

-

-

-

According to the program for cleaning

and disinfection device

D–W:

FD–W:

Drinking water

Fully desalinated water (demineralized, low microbiological contamination: drinking water quality

at least)

*Recommended: BBraun Helimatic Cleaner alkaline

Modifications carried out on medical technical equipment may result in loss of guarantee/warranty rights and forfeiture of applicable licenses.

Service addresses

Aesculap Technischer Service

Am Aesculap-Platz

78532 Tuttlingen / Germany

Phone:

+49 (7461) 95-1602

Fax:

+49 (7461) 16-5621

E-Mail:

ats@aesculap.de

Or in the US:

Attn. Aesculap Technical Services

615 Lambert Pointe Drive

Hazelwood

MO, 63042

Aesculap Repair Hotline

Phone:

+1 (800) 214-3392

Fax:

+1 (314) 895-4420

Other service addresses can be obtained from the address indicated above.

Disposal

► Adhere to national regulations when disposing of or recycling the product, its components and its packaging!

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Distributor in the US/Contact in Canada for product information and

complaints

Aesculap Inc.

3773 Corporate Parkway

Center Valley, PA, 18034,

USA

TA-Nr. 014014

07/13

V6