Revision Rev 1

Page 2

Handle with lock

Aesculap®

AdTec

mini instrument

system

Sovereign®

mini System

Legend

1

2

3

4

5

6

7

8

9

Handle (complete)

Movable part of the handle

HF pin

Star wheel

Actuating lever

Switch (lubrication point)

Jaw insert (lubrication point)

Pressure bar

Outer tube

► Press actuating lever 5 to release the ratchet mechanism.

► To activate the ratchet mechanism, release actuating lever 5.

Switch 6 can be used for permanently deactivating the ratchet mechanism.

► To deactivate the ratchet mechanism on handle 1:

– Position switch 6 as shown in I.

The switch 6 clicks into the front position.

► To activate the ratchet mechanism on handle 1:

– Position switch 6 as shown in II.

The switch 6 clicks into the rear position.

Disassembling

Note

For disassembling the product, also see additional series of illustrations A.

► Deactivate the ratchet mechanism on handle 1 with lock:

– Position switch 6 as shown in I.

► Detach the shaft from handle 1:

Symbols on product and packages

Caution, general warning symbol

Caution, see documentation supplied with the product

– Push star wheel 4 back, hold it there, and remove the shaft.

– Extract jaw insert 7, together with outer tube 9, from handle 1.

► Disassemble the shaft:

– Remove outer tube 9 from jaw insert 7.

– Rotate pressure bar 8 counterclockwise by 90° and extract it from jaw insert 7.

Assembling

Note

For assembling the product, also see additional series of illustrations B.

Intended use

All professional disciplines that use endoscopy:

Aesculap's Sovereign mini System is indicated for use

■in Cutting,

preparation, and grasping of tissues

adult and

pediatric diagnostic and therapeutic

■general

Biopsies

endoscopy and laparoscopy surgery.

■ Suturing

► Deactivate the ratchet mechanism on handle 1 with lock:

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).

Risk of injury from ignition or explosion of flammable gases!

Sparks may occur when using the HF device as directed.

► Observe the safety guidelines in the instructions for use of the HF device.

WARNING

WARNING

Thermal injuries to patients/users due to insufficient insulation of leads in active

accessories!

► Adjust the HF device to an appropriate setting to ensure that the peak output

voltage does match or not exceed the accessory voltage rating specified for

the product.

► Use the instrument only with an insulated outer tube.

The manufacturer has tested the product and verified that its insulation can withstand 300 reprocessing cycles. In

clinical practice, the service life will depend on the individual intraoperative usage and the hospital's specific reprocessing conditions.

► Adjust the HF power output to the intended surgical intervention. Take into account clinical experience or reference values.

► Select the lowest possible HF power output.

► Keep the product’s contact surfaces clean during surgery. Remove encrusted tissue residues or body fluids with

a moistened swab.

The plug end of the product is fitted with the following connector: pin, 4 mm, sprung.

Refer to our brochures to find a compatible cable.

The accessory voltage rating of the product is 2 kVp.

The accessory voltage rating must exceed or match the peak output voltage with which the product is operated in

combination with a suitable HF device at an appropriate operating mode/setting (see IEC/DIN EN 60601-2-2).

To avoid HF burns:

► Always keep the working end of the product in the user’s field of vision whenever the HF power is activated.

► Prior to activating the HF device, check that the working end of the product is not touching any electrically conductive accessories.

► Prior to each use, visually inspect the product for: damage or surface changes to the insulation.

► Never place the product on or next to the patient.

► When using accessories for endoscopy or laparoscopy, deactivate the automatic switch-on mode of the HF

device.

► Follow the instructions for use of the HF device.

Safe operation

Risk of injury and/or malfunction!

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

WARNING

– Position switch 6 as shown in I.

► Assemble the shaft:

►

►

– Slide pressure bar 8 into jaw insert 7 and rotate it clockwise by 90°.

– Slide outer tube 9 onto jaw insert 7 as far as it will go.

Hold the assembled shaft at jaw insert 7 with one hand.

With the other hand, hold handle 1 at star wheel 4. The moveable part of the handle 2 must remain freely moveable.

Push the shaft into handle 1, making certain that the notch on pressure bar 8 is aligned with the mark on star

wheel 4.

The moveable part of the handle 2 moves upward.

The shaft engages automatically when it reaches the stop.

Test the instrument for proper functioning by opening and closing the jaws.

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.

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.

Disassembling the product before carrying out the reprocessing procedure

Risk of injury when using the product beyond the field of view!

► Apply the product only under visual control.

WARNING

► To open and close the distal end of the jaws:

– Open and close the moveable part of the handle 2.

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

► Open up instruments with hinges.

Page 3

Preparations at the place of use

Manual cleaning/disinfection

► 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.

► Prior to manual disinfecting, allow water to drip off for a sufficient length of time to prevent dilution of the dis-

Preparation before cleaning

infecting solution.

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

► Repeat the cleaning /disinfection process if necessary.

Manual cleaning with immersion disinfection

► Dismantle the product prior to cleaning, see Disassembling.

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

-

-

-

-

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 according to the manufacturer’s instructions which

– are approved for the material in question (e.g., aluminum, plastics, highgrade steel),

► Observe specifications regarding concentration, temperature and exposure

time.

► Do not exceed the maximum permitted cleaning temperature of 93 °C.

Immersion treatment in a 3 % H2O2 solution for approx. 5 minutes is a particularly effective and gentle method to

dissolve encrustations from HF instruments. Subsequently, the debris can be removed by hand, with a medium-hard

brush and or in an ultrasonic bath. This is followed by the conventional reprocessing steps.

► Use suitable cleaning/disinfecting agents if the product is put away in a wet condition. To prevent foam formation and reduced effectiveness of the process chemicals: Prior to mechanical cleaning and disinfection, rinse the

product thoroughly with running water.

► Carry out ultrasound cleaning:

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

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

disinfection.

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

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

Validated cleaning and disinfection procedure

Validated procedure

Specific requirements

Reference

Manual cleaning with immersion

disinfection

■

■

■

Chapter Manual cleaning/disinfection and sub-chapter:

■

Handle

■

Manual cleaning with ultrasound

and immersion disinfection

■

Shafts

■

■

■

■

Mechanical alkaline cleaning and

thermal disinfection

■

■

Handle

■

■

■

Manual pre-cleaning with brush

and subsequent mechanical alkaline cleaning and thermal disinfection

■

■

■

■

Shafts

■

■

■

Cleaning brush, e.g., GK469200

20 ml disposable syringe

When cleaning products with

movable hinges, ensure that

these are in an open position

and, if applicable, move the

joint while cleaning.

■

Chapter Manual cleaning with

immersion disinfection

Drying phase: Use a lint-free

cloth or medical compressed air

Cleaning brush, e.g., GK469200

20 ml disposable syringe

When cleaning instruments

with movable hinges, ensure

that these are in an open position and, if applicable, move

the joint while cleaning.

Chapter Manual cleaning/disinfection and sub-chapter:

■

Chapter Manual cleaning with

ultrasound and immersion disinfection

Drying phase: Use a lint-free

cloth or medical compressed air

Place the instrument in a tray

that is suitable for cleaning

(avoiding rinsing blind spots).

Chapter Mechanical cleaning/disinfecting and sub-chapter:

■

Connect components with

lumens and channels directly to

the rinsing port of the injector

carriage.

Chapter Mechanical alkaline

cleaning and thermal disinfecting

Keep working ends open for

cleaning.

Place instruments in the tray

with their hinges open.

Cleaning brush, e.g., GK469200

20 ml disposable syringe

Place the instrument in a tray

that is suitable for cleaning

(avoiding rinsing blind spots).

Connect components with

lumens and channels directly to

the rinsing port of the injector

carriage.

Keep working ends open for

cleaning.

Place instruments in the tray

with their hinges open.

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

■

■

D–W:

FD–W:

Drinking water

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

at least)

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.

► 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.

Phase V

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

and disinfection procedure.

Manual cleaning with ultrasound and immersion disinfection

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

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

-

-

-

-

Chapter Manual pre-cleaning

with a brush

Chapter Mechanical alkaline

cleaning and thermal disinfecting

D–W:

FD–W:

Drinking water

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

at least)

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

► 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.

► Drain any remaining water fully.

Page 4

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 running water.

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

► Rinse lumens with an appropriate disposable syringe at least five times.

► Drain any remaining water fully.

Phase V

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

and disinfection procedure.

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

■

■

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

Note

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

D–W:

FD–W:

Drinking water

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

at least)

*Recommended: BBraun Helimatic Cleaner alkaline

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/Note

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

■

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

■

III

Intermediate

rinse

>10/50

1

FD-W

-

IV

Thermal disinfecting

90/194

5

FD-W

-

Drying

-

V

-

-

0.5 % working solution

– pH = 11*

III

Mechanical cleaning/disinfecting

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).

Concentrate, alkaline:

– pH = 13

– <5 % anionic surfactant

Inspection, maintenance and checks

Concentrate, alkaline:

– pH = 13

– <5 % anionic surfactant

0.5 % working solution

– pH = 11*

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,

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

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

►

►

►

►

►

►

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.

Assemble dismountable products, see Assembling.

Check for compatibility with associated products.

Packaging

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.

Steam sterilization

Manual pre-cleaning with a brush

Note

The product can be sterilized either in disassembled or in assembled condition.

Mechanical cleaning/disinfection with manual pre-cleaning

Appropriately protect products with fine working tips.

Store products with ratchet locks fully opened or locked no further than in the first notch.

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 sterile Aesculap containers).

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

Phase

Step

T

[°C/°F]

t

[min]

Conc.

[%]

Water

quality

Chemical

Note

To avoid breakage due to stress crack corrosion, sterilize the instruments with the lock fully open or locked no further

than on the first ratchet tooth.

I

Disinfectant

cleaning

RT (cold)

>15

2

D–W

Aldehyde-free, phenol-free,

and QUAT-free concentrate,

pH ~ 9*

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces (e.g. by

Rinsing

RT (cold)

-

– Steam sterilization using 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 instruments 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.

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.

opening any valves and faucets).

► Validated sterilization process

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

*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.

Storage

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

Page 5

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.

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:

Aesculap Inc.

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.

Accessories/Spare parts

For accessories and spare parts, see brochure C 28011 or visit http://www.endoscopy-catalog.com

Disposal

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

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

complaints

3773 Corporate Parkway

Center Valley, PA, 18034,

USA

TA-Nr.

013248 05/12

Änd.-Nr. 44801

SOP-AIC-5001557

Rev. 1V60316