macro-Line Wagner Dermatome GB230R micro-Line Wagner DermatomeGB231R

Coupling the macro-Line Wagner Dermatome GB230R Damage to the handpiece due to incorrect handling or operation! ► Handpiece must only be coupled while the motor is inactive. CAUTION ► Release clamping lever 11 towards the OPEN position. ► Push the handpiece onto centering lug 20 until the handpiece touches face plate 21 and lug 24 engages in the

recess at the handpiece.

Taking skin grafts To familiarize with the operation of the dermatome prior to its first surgical application, the user should carry out some test cuts on a specimen. ► Stretch flabby skin. ► With the cutting surface in contact with the skin to be cut, smoothly push forward the dermatome, applying gentle pressure. Be careful not to cant the dermatome. ► For extremely thin grafts, use tweezers to lay up the detached graft on surface 14 from time to time.

6.

Validated reprocessing procedure

6.1

General safety instructions

► Tighten clamping lever 11 towards the CLOSE position.

Move the clamping lever to be parallel with the handpiece. ► Tighten down the clamping lever 11. ► Undo fixing screw 12 with hexagon wrench 9 until the denticulation 13 disengages. ► Move clamping lever 11 to a position parallel to the drill handpiece. ► Engage denticulation 13 and tighten clamping bolt 12.

Uncoupling the macro-Line Wagner Dermatome GB230R ► Release clamping lever 2 towards the OPEN position. ► Remove the handpiece.

Coupling the micro-Line Wagner Dermatome GB231R Damage to the handpiece due to incorrect handling or operation! ► Handpiece must only be coupled while the motor is inactive. CAUTION ► Push the handpiece onto centering lug 29 until it touches face plate 28 and snaps into position.

Uncoupling the micro-Line Wagner Dermatome GB231R ► Press release button 30. ► Remove the handpiece.

5.2

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 up-to-date information about 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.

6.2

Single-use products

Function checks

Note The function checks must be carried out prior to every surgical application of the product!

WARNING

Infection hazard for patients and/or users and impairment of product functionality due to reuse. Risk of injury, illness or death due to contamination and/or impaired functionality of the product! ► Do not reprocess the product!

Test run ► Check that the dermatome blade is securely seated. ► Briefly run the dermatome. ► Follow the advisories/procedure for inspection, maintenance and checks, see Maintenance.

5.3

Safe operation Risk of burns to patient and user due to hot motor/hot tool! ► Put down the motor/hot tool beyond reach of the patient. ► Use a cloth to protect against burns when changing the motor or tool. WARNING

WARNING

Risk of injury and material damage due to inappropriate use of handpieces or motors! ► Always follow the safety advice and information given in the instructions for use of the handpieces and motors. ► Do not exceed the specified maximum motor speed. Risk of injury and/or malfunction! ► Always carry out a function check prior to using the product.

WARNING Risk of injury when using the product beyond the field of view! ► Apply the product only under visual control. WARNING

Designation

Art. no.

Dermatome blades

GB228R

6.3

6.4 Risk of infection and contamination from unsterile parts! ► Use only sterile/sterilized parts in the sterile area.

Preparations at the place of use

► 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.

6.5 WARNING

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.

Preparation before cleaning

Adjusting the cutting thickness

► Open the clamping levers 2 to remove the dermatome blade. ► Dismantle flap rod 23 of the dermatome, see Dismantling the flap rod. ► Prior to the first mechanical cleaning/disinfection process, mount Eccos holder GB682R in a suitable tray (e.g.

Note Consider the skin condition (e.g. with regard to the age of the patient)!

► Carry out non-fixating/NaCl-free pre-cleaning immediately after use.

► In case of difficulties with the product, see Troubleshooting list. ► Adjust the cutting thickness with the setting lever 16. Lock 17 of setting lever 16 prevents inadvertent changes

of the cutting depth setting. ► Read the cutting thickness on scale ring 15 (gradation 1/10 mm).

Adjusting the cutting width Risk of injury through improper opening of the flaps. Risk of cuts by the dermatome blade ► Always use the flap tabs for lifting the flaps. WARNING ► Turn up the number of flaps 6 according to the required cutting width, until they click into place (1 flap width

= 8 mm). Note The width of the skin graft is 2 mm less than the cutting width set by the flaps!

JF214R).

6.6

Cleaning/disinfection

6.8

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).

Product-specific safety instructions for the reprocessing procedure

CAUTION

Damage to, or destruction of the product caused by mechanical cleaning/disinfection! ► Only clean and disinfect the macro-Line Wagner Dermatome GB230R manually.

CAUTION

Risk of damage to the product GB230R due to inappropriate cleaning/disinfecting agents! ► Only use cleaning/disinfecting agents approved for surface cleaning. Follow the manufacturer’s instructions for the respective cleaning/disinfecting agent.

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

Mechanical neutral or mild alkaline cleaning and thermal disinfecting Machine type: single-chamber cleaning/disinfection device without ultrasound

Damage to the product GB231R 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 plastic material and high-grade steel, – do not attack softeners (e.g. in silicone). ► Observe specifications regarding concentration, temperature and exposure time. ► Do not exceed the maximum allowable temperature of 60 °C.

CAUTION

Phase

Step

T [°C/°F]

t [min]

Water quality

Chemical

I

Prerinse

<25/77

3

D–W

-

II

Cleaning

55/131

10

FD-W

Neutral:

■ Concentrate: – pH neutral – <5 % anionic surfactant

■ 0.5 %* working solution Mildly alkaline:

■ Concentrate: – pH = 9.5 – <5 % anionic surfactant

■ 0.5 % solution

► Dry the product for at least 10 minutes at a maximum of 120 °C.

Note The indicated drying temperature is a guide temperature only. It must be checked taking into account the specific conditions (e.g. load) and adjusted if applicable. ► Do not clean motors/handpieces by ultrasonic treatment and do not immerse them in any liquids. To avoid the

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

risk of corrosion/malfunctioning, allow any fluid that has entered the product to drain out immediately.

Validated cleaning and disinfection procedure Validated procedure

Special features

Reference

Manual cleaning and wipe disinfection

■ When cleaning products with movable hinges,

Chapter Manual cleaning/disinfecting and subsection:

■ GB230R ■ GB231R

ensure that these are in an open position and, if applicable, move the joint while cleaning.

■ Chapter Manual cleaning

■ Drying phase: Use a lint-free cloth or com-

and wipe disinfecting

pressed air for medical purposes

■ Ensure that the product is positioned in such a way that water will not enter the product e.g. through coupling interfaces. (Immediately remove any fluid that entered the product inadvertently.) Mechanical neutral or mild alkaline cleaning and thermal disinfecting

■ Insert the product in its proper position in the Eccos holder.

■ Follow the instructions for use of the Eccos

■ GB231R

6.7

holder.

D–W: FD–W:

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner neutral ► Check visible surfaces for residues after mechanical cleaning/disinfecting. ► Repeat the cleaning/disinfecting process if necessary.

6.9

Chapter Mechanical cleaning/disinfecting and subsection:

■ Chapter Mechanical neutral or mild alkaline cleaning and thermal disinfecting

Inspection, maintenance and checks

► Allow the product to cool down to room temperature. ► Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged. ► After every cleaning and disinfection, lubricate the product at the lubrication points 10, coupling 19/27 and slid-

ing guides 4/5 with a drop of STERILIT Power Systems drip lubricator GA059. ► Check the product for any damage, abnormal running noise, overheating or excessive vibration. ► Inspect tools for broken, damaged or blunt edges. ► Set aside the product if it is damaged. ► Prior to an extended period of non-use, always store attachments cleaned and dried according to the instruc-

tions.

6.10 Packaging

Manual cleaning/disinfecting

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

► Always follow the instructions for use of the respective packaging and storage devices (e.g. instructions for use

infecting solution. ► After manual cleaning/disinfection, check visible surfaces visually for residues. ► Repeat the cleaning/disinfection process if necessary.

► Insert the product GB231R in its proper position in the Eccos holder, or put it on a tray in such a way that the

Manual cleaning and wipe disinfecting

► Place the product GB230R on a tray in such a way that it is protected against damage. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

TA009721 for the Aesculap Eccos storage system). product is protected against damage.

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemical

I

Cleaning

RT (cold)

-

-

D–W

-

Note The product may only be sterilized when dismantled.

II

Drying

RT

-

-

-

-

III

Wipe disinfection

-

>1

-

-

Meliseptol HBV wipes 50 % Propan-1-ol

► Check to ensure that the sterilizing agent will come into contact with all external and internal surfaces. ► Validated sterilization process

IV

Final rinse

RT (cold)

0.5

-

FD-W

-

V

Drying

RT

-

-

-

-

D–W: FD–W: RT:

6.11 Steam sterilization

Drinking water Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) Room temperature

Phase I ► Clean the product under running faucet water, using a suitable cleaning brush until all visible residues have been removed from the surfaces. ► Mobilize non-rigid components, such as set screws, links, etc. during cleaning. Phase II ► Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning and disinfection procedure. Phase III ► Wipe all surfaces of the product with a single-use disinfectant wipe. Phase IV ► After the specified exposure time (at least 1 min), rinse the disinfected surfaces under running FD water. ► 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.

– 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.

6.12 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.

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

7.

Maintenance

To ensure reliable operation, the product must be maintained at least once a year. For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

8.

Troubleshooting list

12.

Malfunction

Detection

Cause

Remedy

Gearing heats up

Loud/intense noise

Gearing worn

Have repaired by manufacturer

Motor runs too slowly

Faint running noise

Friction between sliding surface and dermatome blade

Lubricate sliding guide with STERILIT Power Systems drip lubricator GA059

Dermatome blade not moving

Motor runs, but gearing not engaged

Defective gearings

Have repaired by manufacturer

Lack of cutting performance

Cutting edge worn

Dermatome blade blunt

Replace dermatome blade

Skin graft shows perforations after removal

Scratches, grooves or dents on the dermatome head

Components of the dermatome head damaged

Have repaired by manufacturer

Varying graft thickness (along the width of the graft)

Light gap at dermatome blade not parallel

Dermatome out of adjustment (damage due to impact or drop)

Have repaired by manufacturer

Varying graft thickness (along the length of the graft)

Dents

Dermatome out of adjustment (damage due to impact or drop)

Have repaired by manufacturer

Irregular bleeding from skin

Varying pressure and operating angle during the removal of the skin

Perform test cuts to determine the graft thickness

9.

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 -1601 Fax: +49 (7461) 14 -939 E-Mail: [email protected] 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.

10.

Accessories/Spare parts

Art. no.

Designation

GB020R

Hexagon wrench

GB228R

Dermatom blades (pack of 10)

GB682R

Eccos holder (for GB231R)

GB459R

Eccos mounting set for holders

GA059

STERILIT Power Systems drip lubricator

TA005344

Instructions for use GB230R/GB231R

11.

Technical data

Classification acc. to Directive 93/42/EEC Art. no.

Designation

GB230R

macro-Line Wagner Dermatome

Class IIa

GB231R

micro-Line Wagner Dermatome

IIa

Weight

approx. 770 g

Maximum motor speed

20 000 1/min

Gear ratio

6:1

Max. cutting width

78 mm

Strokes/min

3 000

Blade travel

3.0 mm

Disposal

Note The user institution is obliged to process the product before its disposal, see Validated reprocessing procedure. ► Detailed information concerning the disposal of the product is available through your national B. Braun/Aesculap

agency, see Technical Service.

13.

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

Aesculap Inc. 3773 Corporate Parkway Center Valley, PA, 18034, USA TA-Nr. 005344

09/16

V6

Änd.-Nr. 55513