Acculan 4 GA340 Instructions for Use V6 July 2020

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Aesculap® Acculan 4 Dermatome GA340 / Dermatome 0.1 mm GA341 Legend 1 Product (Dermatome) 2 Trigger (for oscillation frequency control) 3 Safety catch 4 Battery bay 5 Locking pin 6 Sterile funnel 7 Battery 8 Lid 9 Lid release element 10 Battery removal device 11 Dermatome blade 12 Sliding surfaces 13 Blade cover 14 Roll pin 15 Clamping lever 16 Blade guide peg 17 Pusher dog 18 Setting lever 19 Lock (of setting lever) 20 Dial wheel 21 Surface 22 Guide slots 23 Flap rod 24 Flaps 25 Flap tab 26 Nut 27 Symbol for alignment of flaps (on the flap rod)

Labeling of electrical and electronic devices pursuant to directive 2002/96/EG (WEEE)

Classification Type BF

Manufacturer’s batch designation Manufacturer serial number Manufacturer order number Temperature limits during transport and storage

Air humidity limits during transport and storage

Atmospheric pressure limits during transport and storage

S9

Operating mode According to US federal law, this product may only be sold by a physician or by the order of a physician CE mark according to Regulation (EU) 2017/745 Medical device

The depictions are schematic only.

Motor speed control

Symbols on product and packages Rotational direction for loosening the nut

Caution Observe important safety information such as warnings and precautions in the instructions for use.

YYYY-MM

Two-dimensional machine readable code The code contains a unique serial number that can be used for electronically tracking single instruments. The serial number is based on the worldwide standard sGTIN (GS1). Manufacturer

Date of manufacture

Follow the instructions for use

2

Direction of rotation for tightening the nut

Maintenance label Indication of the next maintenance appointment (Date: Year-Month)

Alignment of flaps on the flap rod

Contents 1. 1.1 1.2 2. 2.1 2.2 2.2.1 2.3

About this document... Scope... Warnings... General information... Intended use... Main functions and design characteristics... Operating mode... Indications...

3 3 3 3 3 3 3 4

en 2.4 2.5 3. 4. 4.1 4.2 4.3 5. 6. 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7 6.1.8 6.2 6.3 6.3.1 6.3.2 6.3.3 6.3.4 7. 7.1 7.2 7.3 7.4 7.5

Absolute contraindications... 4 Relative contraindications... 4 Safe handling... 4 Product description... 4 Scope of supply... 4 Components required for operation... 4 Operating principle... 4 Preparation... 4 Working with the device... 4 System set-up... 4 Inserting the rechargeable battery... 5 Intraoperative battery change... 5 Removing the rechargeable battery... 5 Protection against inadvertent activation... 5 To mount the flap rod and flaps... 5 Inserting the dermatome blade... 6 Removing the dermatome blade... 6 Intraoperative storage... 6 Function checks... 6 Safe operation... 6 Adjusting the cutting thickness... 6 Adjusting the cutting width... 6 Operating the product... 6 Taking skin grafts... 7 Validated reprocessing procedure... 7 General safety notes... 7 General information... 7 Reusable products... 7 Preparations at the place of use... 7 Disassembling the product before carrying out the reprocessing procedure... 7 7.5.1 Removing the flap rod of the dermatome... 7 7.6 Preparation before cleaning... 7 7.7 Single-use products... 7 7.8 Product-specific safety instructions for the processing procedure... 8 7.9 Manual cleaning with wipe disinfection... 8 7.10 Automatic cleaning/disinfection with manual pre-cleaning . . 9 7.10.1 Manual pre-cleaning with a brush... 9 7.10.2 Mechanical alkaline cleaning and thermal disinfection... 9 7.11 Inspection, maintenance and checks... 10 7.12 Packaging... 10 7.13 Steam sterilization... 10 7.14 Storage... 10 8. Maintenance... 10 9. Troubleshooting list... 10 10. Technical Service... 12 11. Accessories/Spare parts... 12 12. Technical data... 12 12.1 Classification according to Regulation (EU) 2017/745... 12 12.2 Performance data, information about standards... 12 12.3 Nominal operating mode... 12 12.4 Ambient conditions... 12 13. Disposal... 13

1.

About this document

1.1

Scope

These instructions for use apply to the products listed below: Art. no.

Designation

GA340

Dermatome

GA341

Dermatome 0.1 mm

► For instructions for use of specific items and information on material

compatibility, see B. Braun eIFU at eifu.bbraun.com

1.2

Warnings

Warnings indicate risks to patients, users, and/or the product that could develop while using the product. Warnings are marked as follows: DANGER Indicates a potential danger. If it is not prevented, death or severe injuries may result. WARNING Indicates a potential danger. Minor or moderate injuries may result if this is not prevented. CAUTION Indicates a potential damage to property. The product may become damaged if it is not prevented.

2.

General information

2.1

Intended use

Task/Function When combined with a dermatome blade, the Dermatome GA340 / Dermatome 0.1 mm GA341, is used to obtain split skin grafts with a thickness that can be set. Application Environment The product fulfills the requirements for type BF pursuant to IEC/DIN EN 60601-1 and is used in operating rooms in sterile environments of explosion risk areas (such as areas with pure oxygen or anesthesia gases).

2.2

Main functions and design characteristics

Oscillation frequency

min. 0 rpm to max. 6 500 rpm

2.2.1 Operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) ■ 60 second application, 60 second pause ■ 10 repetitions ■ 30 min cooling time ■ Max. temperature 48 °C Electrical systems generally heat up during continual operation. It is advised to give the system a break after use to cool down, as listed in the table on operating mode. Heating depends on the tool used and the load. After a certain number of repetitions, the system should cool down. This procedure prevents the system overheating as well as possible injury to the patient or user. The user is responsible for the use and adherence to the pause sequence described.

3

en 2.3

Indications

Type and area of application depend on the selected tool.

2.4

Absolute contraindications

The product is not approved for use in the central nervous system or central circulatory system.

2.5

Relative contraindications

The safe and effective use of the product depends greatly on factors that only operators themselves can control. The information provided therefore only represents general conditions. The clinically successful use of the product depends on the knowledge and experience of the surgeon. They must decide which structures can be sensibly treated and must take the safety information and warnings in the instruction for use into account.

3.

Safe handling

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

4.

Product description

4.1

Scope of supply

Art. no.

Name

GA340 GA341

Dermatome – or – Dermatome 0.1 mm

GA678

Sterile funnel

TA014549

Instructions for use of Dermatome GA340/GA341 (flyer)

4.2

Components required for operation

4.3

Operating principle

■ Li-Ion battery short GA346 (charged) ■ Sterile funnel GA678 ■ Lid GA675 ■ Dermatome blade GB228R

The product 1 contains an electric motor, which is powered by a replaceable battery 7. The charged non-sterile battery 7 is inserted into the product 1 via the sterile funnel 6 and sealed with the lid 8 so that it is sterile. The product moves the dermatome blade 11 in oscillation. The oscillation frequency is controlled electronically and can be continuously regulated with the trigger 2.

■ General risk factors associated with surgical procedures are not

5.

described in this documentation. ■ It is the operating surgeon's responsibility to ensure that the surgical procedure is performed correctly. ■ The operating surgeon must have a thorough understanding of both the hands-on and conceptual aspects of the established operating techniques. ► Remove the transport packaging and clean the new product, either manually or mechanically, prior to its initial sterilization. ► Check the functionality and proper condition before using the product. ► Observe "Guidance on Electromagnetic Compatibility (EMC) for Acculan Components" TA022450, see B. Braun eIFU at eifu.bbraun.com ► 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. ► Ensure that the product and its accessories are operated and used only by persons with the requisite training, knowledge, or experience. ► Keep the instructions for use accessible for the user. ► Comply with valid standards. ► Ensure that the electrical installation of the room is consistent with the requirements of IEC/DIN EN. ► Do not operate the product in explosion-hazard areas. ► Sterilize product before use. ► When using ECCOS holder systems, observe relevant instructions for use TA009721, see B. Braun eIFU at eifu.bbraun.com

Aesculap assumes no liability if the following rules are not followed: ► Do not use products from open or damaged sterile packaging. ► Prior to use, inspect the product and its accessories for any visible damage. ► Use the products and their accessories only if they are in perfect technical condition.

Note The user must report all serious incidents occurring in connection with the product to the manufacturer and to the competent authority of the country in which the user is registered.

4

Preparation

6.

Working with the device

6.1

System set-up

WARNING Risk of infection and contamination! Product is delivered unsterilized! ► Sterilize the product before use pursuant to the operating instructions. WARNING Risk of injury and material damage due to accidental activation of the product! ► Products which are not being actively used must be secured against accidental activation (position OFF). 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.

en WARNING Damage to the product if dropped! ► Use the products only if they are in perfect technical condition, see Function check 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. WARNING Risk of injury and/or malfunction due to unrecognized change to cutting setting! The basic calibration of the cutting setting can change if the product is dropped, for instance. ► Do not use product. ► Have the manufacturer inspect the product. 6.1.1 Inserting the rechargeable battery ► Product 1 with the battery shaft 4 must be turned upwards and the sterile funnel 6 (sterile) attached, see Fig. A. ► Battery 7 (non-sterile) is inserted into the battery shaft 4 by a second (non-sterile) person, see Fig. A. Note After the battery has been inserted, multiple signals will sound, which indicate that the product is ready to use.

6.1.3

Removing the rechargeable battery

WARNING Risk of injury from hot battery! Battery may be hot after use in the machine. ► Let the battery cool in the machine and then remove. – or – ► Remove the battery with the battery removal device and let it cool. CAUTION Damage to the battery caused by knocking it against hard objects! ► Only remove battery by tapping the product on the palm of the hand. CAUTION Damage to, or destruction of the batteries due to processing! ► Do not sterilize batteries. Rechargeable battery must be removed after each surgical procedure and prior to processing of the device. Note The battery removal device can be used for easier battery removal, see Fig. B. ► Turn the product 1 with the battery shaft 4 upwards. ► Press both safety catches 9 on the lid 8 at the same time and remove

the lid 8. ► Tightly grasp the battery shaft 4 at the lower end. ► Tap the battery shaft 4 on the palm of the hand until the battery 7

slides out of the battery shaft 4 and can be removed.

► After insertion of the battery, have the sterile funnel 6 (non-sterile)

removed by a second person. ► Attach the lid 8 (sterile) in such a manner that it clicks into place with both release catches 9. Note The sterility of the product is only guaranteed with a correctly placed lid. 6.1.2

Intraoperative battery change

WARNING Risk of injury from hot battery! Battery may be hot after use in the machine. ► Remove the battery with the battery removal device and let it cool. The battery removal device is used for replacing the battery during surgery while ensuring that sterile conditions are maintained. ► Turn the product 1 with the battery shaft 4 upwards. ► Press both safety catches 9 on the lid 8 at the same time and remove the lid 8. ► Attach the sterile battery removal device 10, see Fig. B. ► Gently shake the product 1 with the attached battery removal device 10 with battery compartment 4 facing downwards. The battery 7 slides easily into the battery removal device 10. ► Hand battery removal device 10 including dead battery 7 to a nonsterile person. ► Insert a charged battery 7, see Inserting the rechargeable battery.

6.1.4 Protection against inadvertent activation To prevent inadvertent activation of the product during blade change, for example, the trigger can be locked. To lock trigger: ► Twist the safety catch 3 to position OFF. The trigger 2 is blocked and the product 1 cannot be operated. To unlock trigger: ► Twist the safety catch 3 to position ON. The trigger 2 is unlocked and the product 1 can be operated. 6.1.5

To mount the flap rod and flaps

► Install the flaps 24 on flap rod 23 to the edge of the rear surface.

Observe the symbol 27 on the face of the thread, see Fig. C. ► Screw the nut 26 counterclockwise onto the thread of flap rod 23 (left-handed thread). ► Turn the nut 26 up to the edge of the visible surface. ► Insert and twist the complete flap rod 23 in its guide slots 22 on the side surfaces. ► Push the flap rod 23 laterally all the way so that the cross pin of the flap rod 23 comes to rest in the guide slot 22. ► Tighten nut 26 by turning it counterclockwise.

5

en 6.1.6

Inserting the dermatome blade

DANGER Risk of infection and contamination due to torn or cut surgical gloves! ► Avoid contact with the cutting edge when inserting the dermatome blade. DANGER Risk of injury and material damage due to inadvertent activation of the dermatome while inserting the dermatome blade! ► Prior to inserting the dermatome blade, engage the safety catch, see Protection against inadvertent activation. ► Engage safety catch 3. ► Push both clamping levers 15 in the direction of the arrows, see Fig. C.

Blade cover 13 is now unlocked. ► Open blade cover 13 in the direction of the arrow. ► Securely insert dermatome blade 11 in tappet 17 and blade guide

pin 16, see Fig. D. ► Close blade cover 13. ► Tighten both clamping levers 15 so that roll pin 14 engages in the recess of clamping lever 15. 6.1.7

Removing the dermatome blade

► Release both clamping levers 15. ► Open blade cover 13. ► Remove the dermatome blade 11 from tappet 17 and blade guide

pin 16. 6.1.8 Intraoperative storage Note The ECCOS holder can be used for depositing during surgery. However, the dermatome must not be processed in this position. For the correct processing position, refer to see Validated reprocessing procedure. ► Engage safety catch 3. ► Fold back the clamp of the ECCOS holder. ► Insert product 1 in the ECCOS holder, see Fig. E

6.2

Function checks

The function checks must be carried out prior to each use and after each intraoperative battery change. ► Make certain there is a battery in the battery compartment. ► Ensure that the lid has completely clicked into place. ► Ensure that the dermatome blades are not mechanically damaged. ► Ensure that a dermatome blade is correctly seated in the dermatome. ► Check that the dermatome blade is securely seated. ► Check that the roll pin is securely seated. ► Release product for use (ON position). ► Briefly operate product at maximum oscillation frequency. ► Make certain that the rotational direction is correct in each case. ► Do not use the product if it is damaged or defective. ► Set aside the product if it is damaged.

6.3

Safe operation

WARNING Risk of infection from aerosol formation! Risk of injuries caused by particles scaling off the tool! ► Use suitable protection (such as waterproof protective clothing, face mask, safety gases, suction). WARNING 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. Note The drive motor of the product is operated by a magnetic sensor system. In order to prevent inadvertent activation of the motor, the product may not be exposed to any magnetic fields (such as magnetic instrument pads). Note The slight whistling noise when the product is starting up is due to the construction. 6.3.1 Adjusting the cutting thickness Note The skin condition (e.g. due to age) of the patient must be considered when adjusting the cutting depth (graft thickness). ► Set the cutting depth with setting lever 18. The lock 19 of the setting

lever 18 prevents any unintentional change to the setting of the cutting depth, see Fig. C. ► Read the cutting depth on dial wheel 20 (1/10 mm gradation). ► Follow the troubleshooting information, see Troubleshooting list. 6.3.2

Adjusting the cutting width

WARNING Risk of injury/cuts by the dermatome blade if the flaps are opened incorrectly! ► Always use the flap tabs for lifting the flaps. Note The width of the skin graft will be approx. 2mm less than the cutting width set by the flaps. ► Set the required cutting width by opening the appropriate number of

flaps 24. ► Safely lift flaps 24 by pressing flap tabs 25, see Fig. F.

6.3.3 Operating the product Note The slight whistling noise when the product is starting up is due to the construction. ► Activate trigger 2.

The saw runs at the continuously controlled oscillation frequency.

6

en 6.3.4 Taking skin grafts Note 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 sliding surface in level contact with the skin, push product 1

forward in a smooth movement, applying gentle pressure. Be careful not to cant the product 1. ► For very thin grafts, use a forceps, from time to time, to lay up the resected portion of the graft on surface 21, see Fig. C. ► Turn off the motor and pull the freshly cut skin graft out of the device - or ► Lower the handle and cut off the skin graft with the product 1.

7.

Validated reprocessing procedure

7.1

General safety notes

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 Mechanical reprocessing should be favored over manual cleaning as it gives better and more reliable results. 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/reprocessing technician is responsible for this. Note If there is no final sterilization, then a virucidal disinfectant must be used. Note See also B.Braun eIFU at eifu.bbraun.com for current information on processing and compatibility of material The validated steam sterilization procedure was carried out in the Aesculap sterile container system.

7.2

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 precleaning temperatures >45 °C nor fixating disinfecting agents (active ingredient: aldehydes/alcohols) should 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. 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.

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: ■ 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 link to "AKIBrochures", "Red brochure".

7.3

Reusable products

The service life of the product is limited by damage, normal wear, type and duration of the application, handling, storage and transportation of the product. Careful visual and functional testing prior to next use is the best way to identify a malfunctioning product.

7.4

Preparations at the place of use

► Remove all attached components from the product (dermatome blade,

battery, accessories). ► 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.

7.5

Disassembling the product before carrying out the reprocessing procedure

► Remove battery 7 from the product 1, see Removing the rechargeable

battery. ► Open the clamping levers 15 to remove the dermatome blade 11, see

Removing the dermatome blade. ► Disassemble the product 1 immediately after use, according to instruc-

tions. 7.5.1

Removing the flap rod of the dermatome

► Loosen nut 26 by turning it clockwise (left-handed thread). ► Screw the nut 26 back to the end of the visible surface. ► Press on nut 26 and push flap rod 23 approx. 4 mm to one side. ► Twist flap rod 23 until it can be removed. ► Remove flap rod 23. ► Slide off the flaps 24 from flap rod 23.

The flap rod 23 has been dismantled.

7.6

Preparation before cleaning

► Prior to first mechanical cleaning/disinfection: Mount the ECCOS

holders in a suitable basket (e.g. JC254R) or use the ECCOS basket GB256R equipped with holders. ► Insert the products in the correct position into the ECCOS holders, see Fig. G.

7.7

Single-use products

Dermatome blade GB228R WARNING Risk of infection 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 dermatome blade GB228R. 7

en 7.8

► Do not exceed maximum temperature during thermal disinfection

Product-specific safety instructions for the processing procedure

using 96 °C DI water. ► Dry the product for at least 10 minutes at a maximum of 120 °C.

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 plastic material and high-grade steel, – and which do not affect softeners (e.g., in silicone). ► Do not use cleaning agents that contain acetone. ► Observe information concerning concentration, temperature and exposure time. ► Do not exceed the maximum temperature of 60 °C in chemical cleaning and/or disinfection.

7.9

CAUTION Damage or destruction of the batteries due to processing! ► Protect battery from moisture. Note The drying time listed is only indicative. It has to be checked taking into account the specific conditions (e.g. load) and adjusted if necessary.

Manual cleaning with wipe disinfection

Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water qual- Chemicals ity

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

–

D–W

–

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 de-ionized water (de-mineralized, microbiological, with minimum quality of drinking water) Room temperature Suitable enzyme solution: Helizyme, Cidezyme (the latter for validation purposes)

► Do not clean the product in a ultrasonic bath and do not immerse the

► Flexible components should be rinsed for 20 seconds with the water

product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function.

► After manual cleaning, check visible surfaces and areas of flexible com-

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 difficult to access surfaces with a suitable plastic cleaning brush 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. ► Contamination should be removed with a lint-free cloth or soft brush

moistened with enzyme cleaner.

8

pistol (cold water, at least 2.5 bar). ponents for residues. Phase III ► Mobilize non-rigid components during cleaning. ► Rinse product under running tap water for at least 5 minutes. ► 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. Phase 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).

en 7.10 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 cleaning and disinfection machine used for processing must be serviced and checked at regular intervals. 7.10.1 Manual pre-cleaning with a brush Phase

Step

T [°C/°F]

t [min]

Conc. [%]

Water quality

Chemistry/Note

I

Rinse

RT (cold)

–

–

D–W

Until visually clean

II

Brush

RT (cold)

–

–

D–W

Until visually clean

D–W: RT:

Drinking water Room temperature

► Do not clean the product in a ultrasonic bath and do not immerse the

Phase II ► Mobilize non-rigid components during cleaning. ► Brush difficult to access surfaces with a suitable plastic cleaning brush for at least 1 min. ► After manual preparation, check visible surfaces for residue and repeat the pre-cleaning process as needed.

product in any fluids. Let any fluid incursions drain out immediately, otherwise there is a danger of corrosion and loss of function. Phase I ► Dismantle the flap rod for cleaning. Store flap rods, flaps and nut sep-

arately in tray. ► Mobilize non-rigid components during cleaning.

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).

► Thoroughly clean the product under running water.

7.10.2 Mechanical alkaline cleaning and thermal disinfection Machine type: single-chamber cleaning/disinfection device without ultrasound Phase

Step

T [°C/°F]

t [min]

Water qual- Chemical ity

I

Pre-rinse

<25/77

3

D–W

–

II

Cleaning

55/131

10

FD-W

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

■ Working solution 0.5% – pH ~ 11* III

Intermediate rinse

>10/50

1

FD–W

–

IV

Thermal disinfection

90/194

5

FD–W

–

V

Drying

max. 120/248

min. 10 min

–

–

D–W: Drinking water FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least) *Recommended: BBraun Helimatic Cleaner alkaline

► Insert the product in its proper position in the ECCOS holder. Attach the

battery compartment over the clamp and swivel device into the ECCOS holder until the knob 2 points upwards. ► Ensure that the blade cover 13 is kept open through the entire processing procedure.

► Dismantle the flap rod 23 for cleaning. Store flap rod 23, flaps 24 and

nut 26 separately in tray. ► After automatic cleaning/disinfection, check visible surfaces for resi-

dues and repeat the cleaning/disinfection process as needed.

9

en 7.11 Inspection, maintenance and checks ► Allow the product to cool down to room temperature.

Note Aesculap recommends lubricating the flap rod, flaps, sliding surfaces, and other moving parts, (e.g. knob, cover lids) using STERILIT Power Systems oil spray GB600 prior to every sterilization. Remove excess oil using a lint-free wipe. ► Inspect the product after each cleaning and disinfecting cycle for:

cleanliness, damage, function, abnormal operation noise, excessive heat, or heavy vibration. ► Set aside the product if it is damaged.

7.12 Packaging ► Observe the instructions for use of the respective packaging and hold-

ers (e.g. Instructions for use TA009721 for Aesculap ECCOS holder systems). ► Insert the products in the correct position into the ECCOS holders, see Fig. G. ► Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers). ► Ensure that the packaging will prevent a recontamination of the product.

► 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.

7.14 Storage ► Store sterile products in germ-proof packaging, protected from dust, in

a dry, dark, temperature-controlled area. ► Store sterile single-use GB228R product in germ-proof packaging in a

dry, dark and temperature-controlled room.

8.

7.13 Steam sterilization CAUTION Damage or destruction of the batteries due to processing! ► Do not sterilize the rechargeable battery. Note The product may only be sterilized with the blade, battery and lid as well as opened blade cover all demounted.

9.

Note The product can be sterilized with a mounted flap tab and flaps in the open position.

Maintenance

To ensure reliable operation, the product must be maintained in accordance with the maintenance labeling or at least once a year.

YYYY-MM For technical service, please contact your national B. Braun/Aesculap agency, see Technical Service.

Troubleshooting list

► Have defective products repaired by Aesculap Technical Service, see Technical Service.

Issue

Cause

Detection

Remedy

Product not running

No battery

No battery in the battery shaft

Insert battery.

Battery not charged

No signal tone when inserting the bat- Charge battery in charger. tery

Battery defective

No signal tone when inserting the bat- Have the manufacturer repair the battery. tery

Product in locked OFF position Safety catch is in OFF position

Turn the safety catch to the ON position.

Product defective

Product not running

Have the manufacturer repair the product.

Product becomes hot

Observe operating instructions (nominal operating mode).

Processing/care not performed properly

Product heating

Follow operating instructions (preparation, care). Preventive measure: Oil product before every sterilization.

Fall damage, product defective

Product becomes hot

Return the product to the manufacturer for repairs.

Blunt tool

Heating of tool and product

Change tool.

Product becomes too hot Excessive use

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en Issue

Cause

Detection

Remedy

Insufficient power

Product defective

Insufficient product performance

Observe instructions for use (processing, care). Preventative: lubricate product before every sterilization. Have the manufacturer repair the product.

Steep rise in temperature after a short period of time

Follow operating instructions (operating mode). Return the product to the manufacturer for repairs

Blunt tool

Tool blades worn out

Change tool.

Loud running noise

Defective product drive/ball bearings

Loud, perceptible noise during operation

Follow operating instructions (preparation, care). Preventive measure: Oil product before every sterilization. Return the product to the manufacturer for repairs

Lid cannot be fitted/removed

Lid not compatible

Lid does not click into place

Use the compatible lid for GA340/GA341.

Lid deformed/broken

Lid is hard to fit/remove or cannot be fitted/removed

Have the manufacturer repair the lid.

Connection to product deformed/defective

Lid is difficult or cannot be mounted/removed

Have the manufacturer repair the product.

Battery not compatible

Battery cannot be completely inserted into the battery shaft

Use the compatible battery for GA340/GA341.

Battery deformed/defective

Battery is hard to fit/remove or cannot be fitted/removed

Have the manufacturer repair the battery.

Battery compartment on product deformed/broken

Battery is difficult or cannot be mounted/removed

Have the manufacturer repair the product

Sterile funnel or battery removal device not compatible

Sterile funnel or battery removal device Use compatible sterile funnel or battery removal cannot be attached to the battery com- device for GA340/GA341. partment

Battery cannot be inserted/removed

Sterile funnel or battery removal device cannot be attached

Sterile funnel or battery Sterile funnel or battery removal device removal device deformed/bro- difficult to attach or cannot be ken attached

Change sterile funnel or battery device.

Battery shaft to product deformed/defective

Have the manufacturer repair the product.

Sterile funnel or battery removal device difficult or not attachable

Speed control knob not working

Product in locked OFF position Safety catch is in OFF position

Turn the safety catch into the ON position.

Speed control knob sticks/is defective

Speed control knob not working

Have the manufacturer repair the product.

Dermatome blade not moving

Defective gearings

High operating noise levels of product

Return the product to the manufacturer for repairs

Insufficient cutting performance of dermatome blade

Dermatome blade blunted

Worn cutting edge of dermatome blade Replace dermatome blade

Dermatome maladjusted

Performance of product is inadequate

Have the manufacturer repair the product

Cutting depth uneven/deviating from setting

Skin grafts uneven/too thick/too thin

Mechanical effect (e.g. dropped)

Return the product to the manufacturer for repairs

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en 10. Technical Service

12. Technical data

DANGER Danger to life of patients and users in case of malfunctions and/or failure of protective measures! ► Do not perform any servicing or maintenance work under any circumstances while the product is being used on a patient.

12.1 Classification according to Regulation (EU) 2017/745

CAUTION Modifications of medical devices may result in a loss of potential guarantee/warranty claims and forfeiture of applicable licenses. ► Do not modify the product. ► Contact national B. Braun/Aesculap representative for service and repair.

Art. no.

Name

Class

GA340

Dermatome

IIa

GA341

0.1 mm Dermatome

IIa

12.2 Performance data, information about standards Max. power

approx. 250 W

Max. oscillation frequency

6 500 rpm

Blade travel

approx. 3.1 mm

Cutting depth setting

0.2 mm to 1.2 mm (with GA340) 0.1 mm to 1.1 mm (with GA341) Scale gradations 1/10 mm

Cutting width

max. approx. 78 mm, set by 10 flaps of width 8 mm

Weight (ready for operation)

1.65 kg ±10 %

Dimensions (L x W x H, ready for operation)

277 mm x 113 mm x 83 mm ±5 %

11. Accessories/Spare parts

Application part

Type BF

Art. no.

Name

EMC

IEC/DIN EN 60601-1-2

GA346

Li-Ion battery short

Compliance with standards

IEC/EN 60601-1

GA340345

Nut

GA643817

Flap rod

The product was subject to 500 preparation cycles as a test by the manufacturer and has passed.

GA670210

Flap

GA675

Lid

GA678

Sterile funnel

GA679

Battery removal device

GB228R

Dermatome blade

GB256R

ECCOS set for dermatome

GB487R

ECCOS fixation for lid

GB488R

ECCOS fixation for sterile funnel

GB489R

ECCOS holder for battery removal device

Temperature

GB498R

ECCOS fixation for straight machine

GB600

STERILIT Power Systems oil spray

TA014548

Instructions for use of Dermatome GA340/GA341 (A4 for ring binder)

TA014549

Instructions for use of Dermatome GA340/GA341 (flyer)

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

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12.3 Nominal operating mode Operation with non-periodic load and speed changes (type S9 pursuant to IEC EN 60034-1) ■ 60 second application, 60 second pause ■ 10 repetitions ■ 30 min cooling time ■ Max. Temperature 48 °C

12.4 Ambient conditions Operation

Transport and storage

10 °C to 27 °C

-10 °C to 50 °C

Relative humid- 30 % to 75 % ity

10 % to 90 %

Atmospheric pressure

500 hPa to 1 060 hPa

700 hPa to 1 060 hPa

en 13. Disposal WARNING Risk of infection from contaminated products! ► Observe national regulations when disposing of or recycling the product, its components, and their packagings. Note The operator must process the product before disposal, see Validated reprocessing procedure. The recycling pass can be downloaded from the Extranet as a PDF document under the respective article number. (The recycling pass includes disassembling instructions for the product, as well as information for proper disposal of components harmful to the environment.) Products carrying this symbol are subject to separate collection of electrical and electronic devices. Within the European Union, disposal is taken care of by the manufacturer as a free-of-charge service. ► For questions regarding the disposal of the product, please contact your

local B. Braun/Aesculap representative, see Technical Service.

13