Revision V6

Page 2

Validated reprocessing procedure

Aesculap®

Adapter RT081R and RT046P

General safety instructions

Legend

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.

1

2

3

4

5

6

7

8

9

10

11

12

Fixation screw

Housing

Plastic insert

Locking (turn clockwise)

Lock nut

Unlocking (turn counterclockwise)

Connector

Locking sleeve

Support arm

Arrow symbol

Marking (secure/locked)

“Locked” symbol

Symbols on product and packages

Caution, general warning symbol

Caution, see documentation supplied with the product

Applicable to

► For item-specific instructions for use and information on material compatibility, see also the Aesculap Extranet

at www.extranet.bbraun.com

Intended use

The adapters are used to securely attach optics or trocars to a support arm, using the appropriate plastic insert.

Suitable support arms:

■ Unitrac support arm RT040R

■ M-TRAC support arm FF168R

Safe handling and preparation

CAUTION

Federal law restricts this device to sale by, or on order if 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.

Note

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

hygiene instructions for sterile processing.

Note

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

Note

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

The recommended chemistry was used for validation.

Note

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

Note

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

www.extranet.bbraun.com

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

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.ak-i.org, link to Publications, Red Brochure – Proper maintenance of instruments.

Dismantling prior to carrying out the reprocessing procedure

► Disassemble the product immediately after use, as described in the respective instructions for use.

Preparations at the place of use

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

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

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

Preparation before cleaning

Disassembly

► Disassemble the product prior to cleaning, see Disassembly.

Removing the adapter from the support arm

Cleaning/disinfection

► Release lock nut 5 of the adapter by turning it as indicated by arrow 6 (counterclockwise).

► Rotate locking sleeve 8 counterclockwise to the positive stop.

Product-specific safety instructions for the reprocessing procedure

Mark 11 and arrow symbol 10 are aligned with each other.

► To avoid damage to the adapter: Hold the adapter while detaching it from the support arm 9.

► Push locking sleeve 8 towards the adapter.

Removing the trocar or the optics shaft and the plastic insert

CAUTION

► Turn the locking screw 1 counterclockwise.

► Take the trocar and lens shaft out of the plastic insert 3.

► Remove the plastic insert 3 from housing 2.

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

excessive temperatures!

► Use cleaning and disinfecting agents according to the manufacturer’s instructions which

– are approved for use e.g. on aluminum, plastic materials and stainless steel.

► Observe specifications regarding concentration, temperature and exposure

time.

► Do not exceed the maximum cleaning temperature of 55 °C.

► Carry out ultrasound cleaning:

Assembly

Damage to the trocar and/or optic shaft can occur if they fall out of the adapter!

► Use the adapter with compatible plastic inserts only.

CAUTION

– as an effective mechanical supplement to manual cleaning/disinfecting.

– as a pre-cleaning procedure for products with encrusted residues, in preparation for mechanical cleaning/

disinfecting.

– as an integrated mechanical support measure for mechanical cleaning/disinfecting.

– for additional cleaning of products with residues left after mechanical cleaning/disinfecting.

Validated cleaning and disinfection procedure

►

►

►

►

►

►

►

►

Turn the locking screw 1 counterclockwise.

Insert the compatible plastic insert 3 in housing 2.

Turn locking screw 1 clockwise until plastic insert 3 is fixated.

Insert the trocar and lens shaft into the plastic insert3.

Turn the locking screw 1 counterclockwise until the trocar or optical shaft are firmly seated.

Make certain that mark 11 and arrow symbol 10 are aligned with each other.

Slide the connector 7 through locking sleeve 8 and into support arm 9. Connector 7 should click into place.

Turn locking screw 8 clockwise to the positive stop.

Mark 11 and “Locked” symbol 12 are aligned with each other.

► Tighten locking nut 5 in the direction of arrow 4 (clockwise).

Validated procedure

Special features

Reference

Manual pre-cleaning with ultrasound and brush, and subsequent

mechanical alkaline cleaning and

thermal disinfecting

■

Chapter Mechanical cleaning/disinfection with manual pre-cleaning and subsection:

■

■

Cleaning brush: for example,

TA011944

20 ml disposable syringe

Place the product in a tray that

is suitable for cleaning (avoiding rinsing blind spots).

■

■

Chapter Manual pre-cleaning

with ultrasound and brush

Chapter Mechanical alkaline

cleaning and thermal disinfecting

Page 3

Mechanical cleaning/disinfection with manual pre-cleaning

Note

The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark

according to DIN EN ISO 15883).

Note

The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.

Manual pre-cleaning with 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

-

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:

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

D–W:

Drinking water

RT:

Room temperature

*Recommended: BBraun Stabimed

*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.

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

Storage

infection procedure.

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

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.

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

Technical Service

Risk of injury and/or malfunction!

► Do not modify the product.

WARNING

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

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 -1601

Fax:

+49 (7461) 14 -939

E-Mail:

ats@aesculap.de

Or in the US:

Attn. Aesculap Technical Services

615 Lambert Pointe Drive

Hazelwood

MO, 63042 USA

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!

D–W:

FD–W:

Drinking water

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

at least)

*Recommended: BBraun Helimatic Cleaner alkaline

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

Inspection, maintenance and checks

CAUTION

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

lubrication!

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

JG600 or STERILIT® I drip lubricator JG598).

► Allow the product to cool down to room temperature.

► After each complete cleaning, disinfecting and drying cycle, check that the instrument 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 sort out damaged or inoperative products and have them sent to Aesculap Technical Service, see

Technical Service.

Turn locking screw 1 clockwise into housing 2.

Check for compatibility with associated products.

Packaging

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

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

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

Steam 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).

► 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 fractional 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.

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

complaints

3773 Corporate Parkway

Center Valley, PA, 18034,

USA

TA-Nr. 009907

11/12

V6

Änd.-Nr. 45579